Monday, December 14, 2009

New Macula Eye Disease Discovered

University of Lowa’s scientists have come out with a finding about a new inherited eye disease that affects a part of the retina called the macula. Macula is the part of retina that forms the high-resolution central vision area.

Macula gets damaged in retinal conditions like macular degeneration and can even suffer in case if the person is a patient of diabetes. Macula plays an integral role especially while reading and driving. The new inherited disease came into the attention of the scientists after a person from United States approached a doctor for eye problem. The finding of the disease is expected to increase the comprehension of other common retinal diseases.

Study's lead author Vinit Mahajan, MD, Ph.D., assistant professor of ophthalmology and visual sciences at the University of Iowa Roy J and Lucille A Carver College of Medicine said, "It is rare to find a new inherited eye disease that affects the macula. We thought we had seen them all." He added, "This newly found retinal disease causes abnormal blood vessels in the macula, and these vessels are prone to bleeding. This causes swelling or scars that ''black out'' or blur parts of the field of vision."

"If a doctor saw just one family member, they would probably call this macular degeneration. We knew there was something different, and we had to examine the rest of the family," Mahajan said.

The whole team of scientists evaluated 20 extended family members who had some or other problem with their eyes. Some were reported with central vision loss while others suffered from strabismus which is a condition of where eyes are not aligned. The findings have been reported in the November 9 issue of the Archives of ophthalmology.

For more information go to www.maculardegenerationassociation.org

Thursday, December 3, 2009

First New Embryonic Stem Cell Lines Approved for U.S.

Thirteen embryonic stem-cell lines were approved for use by U.S.-funded researchers today, the first of hundreds of cell colonies that may become available under new polices promised by President Barack Obama.

Stem cells taken from days-old human embryos can be kept alive indefinitely in solution, and have the ability to turn into about 200 cell types in the body. Use of these so-called cell lines is opposed by some people because extracting them destroys the embryos. The stem-cell expansion was announced today by Francis Collins, director of the National Institutes of Health, in a telephone briefing with reporters.

Another 20 lines may be cleared as soon as Dec. 4, the first of “a wave” of approvals that could make hundreds available, Collins said. Obama pledged to end U.S. stem-cell restrictions during his presidential campaign. Congress twice voted to overturn the limits, put in place by President George W. Bush, and Bush vetoed both measures.

“With these restrictions now being lifted, we can now compete, hopefully, with the U.K. and some of the other foreign governments that are running with us,” said Robert Lanza, chief scientific officer of Worcester, Massachusetts-based Advanced Cell Technology Inc., in a telephone interview today. “It would be good for us to be back in the game.”

Advanced Cell gained 1 cent to reach 11 cents in over-the- counter trading at 4 p.m. New York time. The shares more than tripled this year. Geron, the Menlo Park, California company whose application to start the first human trial using embryonic stem cells is pending before the U.S. Food and Drug Administration, rose 76 cents, or 14 percent, to $6.20 in Nasdaq Stock Market trading. The increase was the biggest single-day gain for the company in more than four months.

10,000 Shares

Redwood Partners, a New York-based investment firm, bought 10,000 shares of Geron at $5.70 off the news, said Lisa Duffee, a trader with the company, in a telephone interview today.

“These sorts of stocks get crazy when there’s news,” she said. “They react strongly to the upside or the downside and they’re not expensive. We may hold on to them for a few days to see how much noise it gets. If it really runs up, we could be out today.”

The newly approved lines were created by George Daley, a researcher at Harvard University in Cambridge, Massachusetts and Ali Brivanlou, a researcher at Rockefeller University in New York. They were made using private donations during the eight years that federal funding for stem-cell research was sharply restricted by the Bush administration.

‘Huge Relief’

“It’s been a long time coming and it’s a huge relief,” said Daley, whose research team at the Harvard Stem Cell Institute created 11 of the newly approved lines. “This is the first step toward widely expanded access to hundreds of lines that have been derived since the initial Bush policy of 2001.”

Collins said his agency has approved 31 grants totaling $21 million that have been held up until new cell lines were reviewed and approved. The scientists awarded the grants can now choose which approved cell lines to work with, he said.

“This is an opportunity to celebrate the science that can now go forward,” Collins said during the briefing. The announcement should end “what has clearly been a time of some frustration on the part of the research community.”

More embryonic stem-cell grant applications are under review by the NIH as part of the $10 billion provided to the agency in the $787 stimulus package passed by Congress in February, Collins said. Those grants are in the second stage of scrutiny at the agency and may lead to more than $10 million in additional awards, he said.

‘Rigorous’ Review

The NIH conducted a “rigorous” review to make sure the stem cells approved today were made from embryos that were freely donated by women who were not compensated or induced in any way to provide them, Collins said. Scientists had to submit evidence that donors were informed of all options on use of their embryos and provided written consent.

David Prentice, a senior fellow for life sciences at the Family Research Council in Washington, described the new approvals as “unfortunate,” saying stem-cell research had yet to produce results.

“This money would be much better spent on adult stem cell research where we are seeing good results for a variety of diseases including stroke, spinal cord injury and multiple sclerosis,” he said.

Eye Diseases

Advanced Cell Technology applied to U.S. regulators last month to start human trials on its embryonic stem-cell treatment for Stargardt’s Macular Dystrophy, which causes untreatable blindness. The treatment resulted in 100 percent restoration of vision in rat studies with no serious side effects, Lanza said.

The stem-cell colony used in the studies, which wasn’t previously approved for federal research funding, is five to ten times as efficient at replacing lost photoreceptor cells as other lines, Lanza said.

The company plans to pursue the treatment for other forms of macular degeneration, which affects as many as 10 million people in the U.S., according to a company statement.

For more information go to www.maculardegenerationassociation.org

Friday, November 27, 2009

Earlier Diagnosis Of Ocular Pathologies Such As Keratitis And Macular Degeneration

Carolina Herrera Ortiz
University of Granada

Researchers from the University of Granada have provided an early diagnosis of certain ocular diseases that are very common today, such as age-related macular degeneration and keratitis, by applying an existing optical technique that had never before been used for this purpose.

Scientists from the UGR have studied the image quality in subjects affected by one of these two pathologies, finding a greater amount of ocular aberrations and a higher level of scattering (term associated with the dispersion that light suffers when passing through the various ocular media) in affected eyes compared with results in healthy eyes. This significantly affects visual performance.

This work has been performed by the researcher Carolina Herrera Ortiz, from the Optics Department at the University of Granada, and directed by professors José Ramón Jiménez Cuesta and Francisco Pérez Ocón.

Age-related macular degeneration (ARMD) is the leading cause of central vision loss in developed countries, and mainly affects people of over 50 years of age. As far as keratitis is concerned, this condition causes inflammation of the cornea and can cause blindness, due to the severe alterations that the corneal surface may suffer.

Optical instruments

To carry out this work, the scientists measured the image quality with two optical instruments and used a psychophysical test for assessing visual performance. Results from patients with ARMD were compared with those obtained from a control group of similar age without any ocular pathology. Thus, the researchers could verify that for individuals affected by this condition there is an increased level of ocular scattering that could be mainly due to the disruption suffered by the light reflected in the damaged retina of the ARMD eyes, because a priori optics are not expected to be altered, since it is a retinal pathology.

On the other hand, optical quality and visual performance have also been studied in patients affected by keratitis. Eyes affected by keratitis present a poorer optical quality and a reduced visual performance that improves significantly after the resolution of the pathology. Nevertheless, once medical treatment ends, eyes that suffered from keratitis still have a worse image quality compared to the contralateral healthy eye, a result that significantly influences visual performance even having reached the normal values of visual acuity.

Visual quality characterization

The results of this research carried out at the UGR will make a full and objective characterization of visual quality in patients affected by any of these ocular pathologies. So far, the use of new techniques for assessing objectively the optic quality of the eye has been limited to studies on refractive or cataract surgery. However, as Carolina Ortiz Herrera suggests, this work "may be of particular interest to establish an early diagnosis of certain ocular diseases such as age-related macular degeneration, the main cause of central vision loss in developed countries."

Furthermore, this technique allows researchers to carry out a monitoring of possible stages of both diseases. Ortiz Herrera stresses the importance of including "both in the clinical practice of optometry and ophthalmology" the use of new techniques that, objectively, could indicate deterioration in vision even when the visual acuity values are normal, since "vision is not only seeing well, but providing quality and comfort."

The results of this PhD research led to two publications in journals of international prestige such as Journal of Modern Optics, Cornea. and a future issue of Current Eye Research.

For more information go to www.maculardegenerationassociation.org

Monday, November 16, 2009

Survey Shows That Americans Lack Significant Knowledge of Age-Related Vision Problems

Macular degeneration and glaucoma among the top areas Americans have the most misunderstanding according to the American Optometric Association

It's a fact of life that eyes change with age, and baby boomers - Americans born between 1946 and 1964 - are at the stage when many are affected by vision problems. Despite the prevalence of Americans affected by these changes, a new survey from the American Optometric Association (AOA) shows a concerning lack of public knowledge and misunderstanding regarding age-related eye diseases and conditions.

According to the AOA's American Eye-Q® survey, which assesses public knowledge and understanding of issues related to eye and visual health, only 18 percent of Americans know that macular degeneration is the leading cause of blindness in adults 65 years of age and older, and less than a quarter of all Americans understand the effects of glaucoma. Even more concerning, 89 percent of Americans incorrectly believe that glaucoma is preventable, when in fact it is only treatable if caught early.

Americans who are 40 years of age or older have probably noticed changes in vision. Difficulties seeing clearly for reading and close work are among the most common problems adults develop between the ages of 41 to 60. According to the Eye-Q® survey, top concerns about the effects of vision problems include not being able to live independently, cited by 45 percent; not being able to see loved ones, 21 percent; being unable to read, 20 percent and losing the ability to drive, 11 percent.

"When left undetected and untreated, many age-related eye diseases can damage your vision permanently," said Mark Wilkinson, O.D., Chair of the AOA's Vision Rehabilitation Section. "The good news is that most people can preserve their vision with proper treatment, so the key is early detection."

Age-related vision disorders baby boomers and seniors should be aware of include:

•Age-related macular degeneration (AMD) - an eye disease that causes loss of central vision. Activities like reading, driving, watching TV and recognizing faces all require clear central vision.
•Diabetic retinopathy - a condition occurring in people with diabetes, which causes progressive damage to the retina, the light-sensitive lining at the back of the eye. If left untreated, it can cause blindness.
•Cataracts - a cloudy or opaque area in the clear lens of the eye. Usually cataracts develop in both eyes, but one may be worse than the other. Cataracts can cause a decrease in contrast sensitivity, a dulling of colors and increased sensitivity to glare.
•Glaucoma - a group of eye diseases characterized by damage to the optic nerve resulting in peripheral vision loss. People at higher risk of developing glaucoma include those with a family history of the disease, older adults, African-Americans and Hispanics.
•Dry eye - a condition where there is an insufficient amount of tears or a poor quality of tears to lubricate and nourish the eye. Tears contribute to clear vision and the health of the front surface of the eye.
•Retinal detachment - tearing or separation of the retina from the underlying tissue. This can be caused by trauma to the eye or head, health problems due to advanced diabetes, and inflammatory disorders of the eye.

The good news is the majority of the American Eye-Q® survey respondents (92 percent) understand that visiting an eye doctor on a regular basis for comprehensive eye exams can help reduce the risk of developing age-related vision problems. The bad news is that respondents were less aware that avoiding smoking (40 percent) and eating a low-fat, low-salt diet (30 percent) can also reduce age-related vision problems.

"Some common warning signs of age-related vision problems include fluctuating vision, seeing floaters or flashes of light, loss of side vision and seeing distorted images," said Dr. Wilkinson. "However, often patients with eye diseases do not have recognizable symptoms until the conditions are quite advanced, so regular comprehensive eye exams are essential for baby boomers and seniors."

Addressing Age-Related Vision Problems

The American Eye-Q® survey also revealed that respondents age 55 and older are taking steps to address their age-related vision problems. Thirty three percent said they limit their night driving; 27 percent use brighter lights; 24 percent use wetting eye drops or artificial tears and 18 percent purchase or request items in large print.

Adding certain nutrients to one's diet every day - either through foods or supplements - can help preserve vision and prevent age-related eye diseases.

The AOA recommends the following eye-healthy nutrients and foods:

•Lutein and zeaxanthin: Colorful fruits and vegetables such as broccoli, spinach, kale, corn, green beans, peas, oranges and tangerines
•Essential fatty acids: Fatty fish like tuna, salmon, or herring; whole-grain foods; chicken and eggs
•Vitamin C: Fruits and vegetables, including oranges, grapefruit, strawberries, papaya, green peppers and tomatoes
•Vitamin E: Vegetable oils, such as safflower or corn oil; almonds and pecans; sweet potatoes and sunflower seeds
•Zinc: Extra-lean red meat, poultry, liver, shellfish, milk, baked beans and whole grains

Dealing with Vision Loss

Comprehensive eye exams are important for Americans of all ages, but become especially important later in life when more Americans develop age-related conditions and begin taking medications more frequently. The AOA recommends that adults over age 60 have a comprehensive eye examination by an optometrist once a year or more frequently if a doctor recommends it.

For patients with age-related vision loss, a specialized examination by an optometrist who treats vision impairment is a critical first step in the care process that focuses on maintaining and/or regaining independence and maximizing useful remaining vision. Prescribed treatment options commonly include specialized reading spectacles, spectacle-mounted telescopes, hand-held magnifiers and telescopes, therapeutic filters, specialized contact lenses, field enhancement treatments, and video magnification technology that both enlarge and enhance the contrast of reading materials.

There also are numerous other assistive products that can help with daily activities for people who have vision impairment, such as large-type books, magazines, and newspapers, books-on-tape, talking wristwatches, self-threading needles, and more. To learn more about vision rehabilitation and available treatment options, talk to an optometrist.

For additional information about aging eyes or to find a doctor of optometry in your area, please visit www.aoa.org.

About the survey:

The fourth annual American Eye-Q® survey was created and commissioned in conjunction with Penn, Schoen & Berland Associates (PSB). From May 21 - 24, 2009, using an online methodology, PSB interviewed 1,000 Americans 18 years and older who embodied a nationally representative sample of U.S. general population. (Margin of error at 95 percent confidence level.)

About the American Optometric Association (AOA):

The American Optometric Association represents approximately 36,000 doctors of optometry, optometry students and paraoptometric assistants and technicians. Optometrists serve patients in nearly 6,500 communities across the country, and in 3,500 of those communities are the only eye doctors. Doctors of optometry provide two-thirds of all primary eye care in the United States.

American Optometric Association doctors of optometry are highly qualified, trained doctors on the frontline of eye and vision care who examine, diagnose, treat and manage diseases and disorders of the eye. In addition to providing eye and vision care, optometrists play a major role in a patient's overall health and well-being by detecting systemic diseases such as diabetes and hypertension.

Prior to optometry school, optometrists typically complete four years of undergraduate study, culminating in a bachelor's degree. Required undergraduate coursework for pre-optometry students is extensive and covers a wide variety of advanced health, science and mathematics. Optometry school consists of four years of post-graduate, doctoral study concentrating on both the eye and systemic health. In addition to their formal training, doctors of optometry must undergo annual continuing education to stay current on the latest standards of care.

For more information go to www.maculardegenerationassociation.org

Monday, November 9, 2009

Medicare to Pay More to Doctors for Avastin

In a recent decision, it was announced that Medicare would now pay more to doctors for administering Avastin to patients. Earlier, Medicare had cut payments for Avastin by 80% and had agreed to pay doctors only $7 per dose which is much lower than the $50 per dose costs incurred by them. In turn, the doctors decided to prescribe the more expensive Lucentis which costs $2000 per dose and is not subject to reimbursement limits!! So, in effect the Medicare policy was costing both the taxpayers and the patients (who now had big copays for the $2000 drug). The only entity benefiting from this was Genentech. Genentech says Lucentis is specially formulated with smaller molecules than Avastin to better penetrate the eye. However, many eye doctors say there is no detectable difference in outcomes for patients. The American Academy of Ophthalmologists estimates about 60 percent of all injections for macular degeneration use Avastin. Now, after this policy reversal, it could cost Genentech money due to decrease in sales of Lucentis. Just shows how short sighted senate policies which do not take the full ramifications into account end up having the counter effect!

For more information go to www.maculardegenerationassociation.org

Tuesday, October 27, 2009

1 shot of gene therapy and children with congenital blindness can now see

Born with a retinal disease that made him legally blind, and would eventually leave him totally sightless, the nine-year-old boy used to sit in the back of the classroom, relying on the large print on an electronic screen and assisted by teacher aides. Now, after a single injection of genes that produce light-sensitive pigments in the back of his eye, he sits in front with classmates and participates in class without extra help. In the playground, he joins his classmates in playing his first game of softball.

His treatment represents the next step toward medical science's goal of using gene therapy to cure disease. Extending a preliminary study published last year on three young adults, the full study reports successful, sustained results that showed notable improvement in children with congenital blindness.

The study, conducted by researchers from the University of Pennsylvania School of Medicine and the Center for Cellular and Molecular Therapeutics at The Children's Hospital of Philadelphia, used gene therapy to safely improve vision in five children and seven adults with Leber's congenital amaurosis (LCA). The greatest improvements occurred in the children, all of whom are now able to navigate a low-light obstacle course—one result that the researchers call "spectacular."

"This result is an exciting one for the entire field of gene therapy," said Katherine A. High, M.D., co-first author of the study and the director of the Center for Cellular and Molecular Therapeutics, the facility that sponsored the clinical trial at The Children's Hospital of Philadelphia. High, an investigator of the Howard Hughes Medical Institute and a past president of the American Society of Gene Therapy, has been a pioneer in translational and clinical studies of gene therapy for genetic disease. "This study reports dramatic results in restoring vision to patients who previously had no options for treatment," said High. "These findings may expedite development of gene therapy for more common retinal diseases, such as age-related macular degeneration."

Although the patients did not attain normal eyesight, half of them (six of 12) improved enough that they may no longer be classified as legally blind. "The clinical benefits have persisted for nearly two years since the first subjects were treated with injections of therapeutic genes into their retinas," said senior author Jean Bennett, M.D., Ph.D., F.M. Kirby professor of Ophthalmology at the University of Pennsylvania School of Medicine. For Bennett, the results build on nearly 20 years of gene studies on hereditary blindness, starting with pioneering work in mice and dogs. "These remarkable results," she added, "have laid a foundation for applying gene therapy not only to other forms of childhood-onset retinal disease, but also to more common retinal degenerations."

The study team reported their findings today in an online article in The Lancet.

"Children who were treated with gene therapy are now able to walk and play just like any normally sighted child," said co-first author Albert M. Maguire, M.D., an associate professor of Ophthalmology at Penn and a physician at Children's Hospital. "They can also carry out classroom activities without visual aids."

Maguire and Bennett have been researching inherited retinal degenerations for nearly 20 years. Leber's congenital amaurosis, the target of this current study, is a group of inherited blinding diseases that damages light receptors in the retina. It usually begins stealing sight in early childhood and causes total blindness during a patient's twenties or thirties. Currently, there is no treatment for LCA.

Walking along a dimly lit, simulated street route, the children were able to negotiate barriers they bumped into before the surgery. Another child, who since birth, could only see light and shadows, stared into his father's face and said he could see the color of his eyes. Later they played soccer together.

For children and adults in the study, functional improvements in vision followed single injections of genes that produced proteins to make light receptors work in their retinas.

The 12 subjects ranged in age from 8 to 44 years old at the time of treatment. Four of the children, aged 8 to 11, are the world's youngest individuals to receive gene therapy for a non-lethal disease (A fifth subject was 17 years old). On the other end of the age scale, the 35-year-old man and 44-year-old woman are the oldest patients to ever receive gene therapy for retinal degeneration.

For the current human trial, the research team used a vector, a genetically engineered adeno-associated virus, to carry a normal version of the gene, called RPE65, that is mutated in one form of LCA, called LCA2, that accounts for 8 to 16 percent of all LCA cases. Jeannette Bennicelli, Ph.D., in Bennett's laboratory, cloned the gene. The clinical vector production facility at Children's Hospital's Center for Cellular and Molecular Therapeutics (CCMT), directed by Fraser Wright, Ph.D., manufactured the vector.

The clinical trial brought together subjects and scientists from two continents. Five patients enrolled in the study were identified at the Department of Ophthalmology at the Second University of Naples, an institution with a long-standing program in researching inherited retinal diseases, under the supervision of Francesca Simonelli, M.D. Two children from Belgium were recruited through Ghent University Hospital, under the supervision of Bart Leroy, M.D., Ph.D. Jennifer Wellman, of the CCMT, directed all local and federal regulatory interactions for the study.

Another co-author, Edwin Stone, M.D., Ph.D., Howard Hughes Medical Institute Investigator and director of the Carver Center, a genetic testing laboratory at the University of Iowa, identified and verified several of the disease-causing mutations in the study subjects.

In April 2008, the current study team published encouraging preliminary results in the New England Journal of Medicine regarding three young adults, the first to receive gene therapy in this current clinical trial. Those subjects showed improvements in their visual function in both objective vision tests and subjective reports by the patients themselves. Patients who could only detect hand movements gained the ability to read lines on an eye chart.

After the first group of three young adults was treated safely, the study team extended gene therapy to five children from the United States, Italy and Belgium, in addition to four other adults. Because animal studies conducted by Bennett and colleagues had shown that visual improvement was age-dependent, the researchers tested the hypothesis that younger human subjects would receive greater benefits from the treatment. "LCA is a progressive disease, so if a treatment was possible, it was plausible to intervene before damage to the retina was severe," said Bennett.

In all, 12 patients received the gene therapy via a surgical procedure performed by Maguire starting in October 2007 at The Children's Hospital of Philadelphia. For each subject, Maguire injected the therapeutic genes into the eye with poorer function. There were three patient cohorts, receiving low, middle and high doses. No serious adverse events occurred in any of the test subjects.

Starting two weeks after the injections, all 12 subjects reported improved vision in dimly lit environments in the injected eye. An objective measurement, which measures how the eye's pupil constricts, showed that all the subjects were able to detect significantly more light after treatment and also showed greater light sensitivity in each patient's treated eye compared to the untreated eye. In addition, before treatment, nine patients had nystagmus, an involuntary movement of the eyes that is common in LCA. After treatment, seven of them had significant improvements in nystagmus.

Some of the most dramatic results, captured on video by the researchers, are apparent as subjects traverse a standardized obstacle course. Before the treatment, the patients had great difficulty avoiding barriers, especially in dim light. After treatment, the children navigated the course more quickly, with fewer errors than before, even at the lowest light levels. Not all the adults performed better on the mobility course, and for those who did, the improvements were more modest compared to the children's.

"In follow-up studies, we will continue to monitor these patients to determine whether this treatment stops the progression of this retinal degeneration," said Maguire. "In the future, we hope to investigate whether other
retinal disease will be amenable to this gene therapy approach."

Thanks to University of Pennsylvania School of Medicine for this article.

For more information go to www.maculardegenerationassociation.org

Thursday, October 22, 2009

Fish intake can help prevent macular degeneration

The addition of omega-3 fatty acids to the diet, particularly in the form of fish, can help prevent the development of age-related macular degeneration vision loss by more than 30 per cent, according to a new study.

Macular degeneration is the leading cause of blindness in people older than 50, and is an eye disease that attacks the central part of the retina called the macula, which controls fine, detailed vision. The condition results in progressive loss of central vision, leaving only peripheral sight, making it difficult to drive a car, read a book or recognize faces.

With an aging population in Canada, the incidence of age-related macular degeneration (AMD) expected to increase by 50 per cent over the next two decades.

Previous research has shown that a high intake of omega-3 fatty acids and fish may slow the progression of macular degeneration in those in the advanced stages of the disease.

The current study, published online in the American Journal of Clinical Nutrition, looked at 1,837 people in the Age-Related Eye Disease Study (AREDS) who had a moderate to high risk of developing advanced macular degeneration.

They found that those with the highest omega-3 fat intake - mainly from fish and seafood - were 30 per cent less likely to progress to advanced AMD over 12 years than their peers who consumed the least.

Those with the highest intake ate the equivalent of about 3 ounces of Atlantic salmon or 5 ounces of rainbow trout per week.

It's thought that an omega-3 fatty acid found in fish called DHA (docosahexaenoic acid) may work to prevent damage to the retina through its anti-inflammatory and antioxidant properties.

Since omega-3 fatty acids cannot be manufactured by the body, it is essential that people get them through their diet., says Canada AM nutrition expert Leslie Beck.

"I would recommend eating oily fish like salmon, trout or sardines twice per week," she says. "If you don't like fish, consider taking a fish oil capsule once or twice daily. If you're a vegetarian, DHA supplements made from algae are available."

Other sources of omega-3 fatty acids include nuts, which also have anti-inflammatory and antioxidant effects and may also reduce the risk of heart disease and type 2 diabetes -- diseases that are linked to AMD.

More studies are underway to investigate the role of the diet and AMD. AREDS2, a five-year randomized trial involving 4,000 people will test the effectiveness of supplementing with certain antioxidants and/or omega-3 fatty acids on the progression to advanced AMD.

For more information go to www.maculardegenerationassociation.org

Tuesday, October 13, 2009

MIT’s Retinal Implant is Moving Forward, But Hasn’t Caught Up with Argus II

By Aaron Saenz

Way back at the beginning of the year we told you about the Argus II, an artificial retina that was helping some blind people to see. MIT researchers from the Retinal Implant Research Group led by John Wyatt are developing their own retinal implant that works along much the same principles. As reported in IEEE’s Transactions on Biodmedical Engineering, Wyatt and his team are currently testing the implants for viability in the eyes of pigs. He hopes in the next three years to move to a new prototype and human testing. However, the Argus II is already there with 20 human patients currently testing those devices.

Diseases like macular degeneration and retinitis pigmentosa are responsible for around 25 million cases of blindness worldwide. Retinal implants have the unique ability to bypass the damaged retinal tissue and stimulate the optical nerves that still function. In this way, the blindness is replaced with a very simplified vision that many users define as hazy and limited. Still, tests for the Argus II have allowed some patients to cook, make out shapes at sporting events, and move more easily through their homes. Current artificial retinas are clearly in their infancy, but as these devices are improved in the next few decades, they may serve as a means to restore near-perfect vision.

Distinguishing between the MIT artificial retina and the Argus II isn’t easy. They both use cameras or sensors embedded on glasses to record visual information that is sent to a processing pack. That pack then wirelessly relays the information to an electrode array implanted directly on the eye. As the electrodes stimulate the optic nerve, patients should see a limited series of light and dark spots that correspond to the original visual information from the glasses. The MIT artificial retina may have a superior casing structure, made of titanium.

The biggest difference between the two implants is where the electrodes attach. While the Argus array is placed on the retina, the MIT implant will be connected subretinally. This will reduce the risk of tearing during implantation. This difference may have important implications as complications during operation could affect long term viability (the MIT team wants the implant to last more than 10 years). In most other ways, the two devices are remarkably similar.

Except of course that Argus II seems to be years ahead in terms of producing a marketable product. Besides the fact that the MIT implant is still being tested for safety while the Argus II is in human trials, there’s also the issue of image resolution. The next version of the device, Argus III, is slated to have many more electrodes in the array (1000 vs. the current 60) which will greatly increase the level of detail available to users. The MIT implant, with 15 channels, has a ways to go to catch up.

Yet, even if the MIT device seems to be lagging behind the Argus, it’s good that there is more than one team in the race. Teams, which we should emphasize, are both making good progress even if they are at different stages. The Argus II, as we’ve said before is being tested in 20 patients with remarkable results. The MIT implant has been proven to be safe in pig eyes for at least 10 months, and the programming algorithms have been thoroughly tested. Both teams are well funded and have the potential to create a viable product at some point in the future. For the millions of blind people who suffer from retinal problems, who makes a retinal implant isn’t so important as long as it gets done.

For more information go to www.maculardegenerationassociation.org

Monday, October 5, 2009

Scientists Develop Antidote For New Class Of Drugs

A new antidote has been developed by scientists which appears to work against a whole new class of drugs called aptamers.The new compound can quickly counteract the action of the drugs, offering a way to reverse the drugs' actions if a patient develops serious side effects.

The compound was designed to work with a new blood-thinner being developed for heart patients undergoing angioplasty to clear out blocked arteries. Such patients need to take blood thinners to prevent blood clots during surgery, but bleeding is a common side effect.

Bruce Sullenger of Duke University Medical Center said that having an antidote on hand would make the treatments safer. His study was published in the journal Nature Medicine.

The antidote agent appears to work against a whole new class of drugs called aptamers.

Sullenger said,"Most drugs target proteins. The type of drugs we're talking about are ribonucleic acids (RNAs) that target proteins.”


"Normally in our body we don't have these types of molecules outside of cells," Sullenger said.

"What we are doing is using agents that will sop up any nucleic acid. It's basically acting like a sponge. We put the sponge in the one compartment where the drug is," he said.

These antidote molecules controlled the activity of eight different aptamer compounds that was tested by the team.

They also tried it in a pig that had been given an aptamer blood thinner compound. "We showed you could rapidly reverse that blood-thinning effect," he said.

Pfizer's Macugen, a treatment for age-related macular degeneration, is the only aptamer drug that has been currently approved for sale by the U.S. Food and Drug Administration. Sullenger confirmed that several others were undergoing test.

Regado Biosciences in Durham, North Carolina is the company that is testing his blood thinner, called REG1.

Sullenger thinks that an antidote to this emerging class of drugs will make them safe."We predict that this advance will significantly expand the number of diseases that can be more safely treated using antidote-controllable agents," he said.

For more information go to www.maculardegenerationassociation.org

Friday, September 25, 2009

Advanced Cell Completing Pre-Clinical Activities in Preparation for IND Filing

WORCESTER, Mass.,

Advanced Cell Technology, Inc. (Advanced Cell, ACT) (OTC: ACTC) provided an update on pre-clinical activities in preparation of its first IND filing with the Food and Drug Administration for its retinal pigment epithelium (RPE) cell program for the treatment of various eye diseases. In the next few weeks, the Company will be completing the preclinical work necessary for filing the IND. To date, no adverse events have occurred in testing. The results will be part of the submission which Advanced Cell expects to submit to the FDA prior to the end of the year.

"We are very pleased with the long-term safety and efficacy data," said Dr. Robert Lanza, ACT's Chief Scientific Officer. "We have carried out pre-clinical studies using these cells in multiple animal models, and to-date have not seen any teratoma formation or untoward pathological reactions. We are optimistic that human embryonic stem cells (hESCs) will serve as a potentially safe and inexhaustible source of RPE for the treatment of a range of macular degenerative diseases."

"We are pleased with the progress we have made in preparation for the FDA submission," said William M. Caldwell IV, Advanced Cell's Chairman and CEO. "In the retina, compromised RPE function can lead to deteriorated vision and photoreceptor loss in both age-related macular degeneration and other forms of degenerative eye disease. We look forward to further studying the role that our RPE cells can play in providing a potential solution to this problem."

For more information go to www.maculardegenerationassociation.org

Friday, September 18, 2009

Patient enrollment for Phase 3 clinical trials of VEGF Trap-Eye completed

Regeneron Pharmaceuticals, Inc. (Nasdaq: REGN) today announced the completion of patient enrollment in two randomized, double-masked, Phase 3 clinical trials evaluating VEGF Trap-Eye in the treatment of the neovascular form of age-related macular degeneration (wet AMD). In each study of the VIEW (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD) program, VEGF Trap-Eye is being evaluated for its effect on maintaining and improving vision when dosed as an intravitreal injection on a schedule of 0.5 milligram (mg) every four weeks, 2.0 mg every four weeks, or 2.0 mg every eight weeks (following three monthly doses), as compared with intravitreal ranibizumab (Lucentis((R)), a registered trademark of Genentech, Inc.) administered 0.5 mg every four weeks during the first year of the studies. As-needed (PRN) dosing with both agents is being evaluated during the second year of each study. These studies are part of the global development program for VEGF Trap-Eye being conducted by Regeneron and Bayer HealthCare AG. Each study has enrolled in excess of the targeted 1,200 patient goal. One-year primary endpoint data from both studies are expected in the fourth quarter of 2010.

VEGF Trap-Eye, an investigational drug, is being developed by Regeneron and Bayer HealthCare AG for the potential treatment of eye diseases, including wet AMD, diabetic macular edema (DME), and Central Retinal Vein Occlusion (CRVO). Regeneron maintains exclusive rights to VEGF Trap-Eye in the United States. Bayer HealthCare has exclusive rights to market VEGF Trap-Eye outside the United States, where the companies will share equally in profits from any future sales of VEGF Trap-Eye.

"Even with recent advances in the treatment of wet AMD, vision is not improved or stabilized in all patients despite monthly office visits and examinations that are inconvenient for these often elderly patients," said George D. Yancopoulos, M.D., Ph.D., President of Regeneron Research Laboratories. "This Phase 3 program is exploring various doses and dosing schedules with our novel anti-VEGF investigational agent to evaluate whether further improvements in vision and/or longer dosing intervals than monthly administration are possible."

For more information go to www.maculardegenerationassociation.org

Wednesday, September 9, 2009

Advice for Seniors with Vision Loss

U.S.News & World Report
By Philip Moeller

Personal experience with macular degeneration.
I have macular degeneration (MD) in both eyes. The Amsler grid is used to determine if you have MD. When I look at the grid with just my right eye all of the lines of the grid seem straight and clear. With my left eye the lines are wavy and distorted. My ophthalmologist diagnosed macular degeneration and sent me to a retina specialist. My mother and both of her siblings had MD, so I was genetically predisposed to get it. The retina specialist took pictures of my macula, the central part of the retina that provides for sharp, clear vision. The pictures showed I had “dry” MD in my right eye, and “wet” in my left. Wet is the worse of the two. Both eyes have “drusens,” which are yellow deposits under the retina. These are early signs of MD but they alone don’t cause severe vision loss. The center of my left retina has a protuberance that is distorting my vision.

Every six weeks I have Lucentis injections in the white part of my left eye. Sounds like it would hurt, but it really doesn’t. They numb the eye before the injection. After the injection I use antibiotic drops for three days to protect against infection. At each visit the doctor takes more pictures to check for change in my left eye. Unfortunately, there’s been no improvement. But it hasn’t gotten worse, so maybe injections have held off progression of the disease. The injections are very costly, so make sure your insurance company agrees to pay before you take them. I also take “AREDS” which is a vitamin complex very rich in eye nutrients. And I take lutein, long considered helpful for eye health. My new glasses include a prism in my left lens that has helped a lot for my distant vision. My reading glasses don’t help much; I actually read better with my left eye closed.

There is an important conference for retina specialists in New York next month. I am hoping to learn results of recent clinical trials to determine other treatment options. I read that vitamin B complex and folic acid have been somewhat effective, but the test results were not at all conclusive. I’m taking them just in case they can help. There are so many researchers working on finding a cure, I'm sure it won't be too long. Good luck and keep your spirits up.

Use the downloadable Amsler grid.
It’s important that anyone diagnosed with macular degeneration check their eyes with the Amsler grid daily and report any changes to the eye doctor. This site also has the latest news articles on the disease. By the way, smokers are 2½ times more likely to get macular degeneration—one more reason to kick the habit.

Exciting new research offers hope for a cure.
I also have macular degeneration. It is the number one cause of visual loss in the U.S., and as people live longer it is expected to become even more prevalent. I read an online article in The Times entitled “Blind to be cured with stem cells” that gave me lots of hope. In London they are experimenting with laboratory trials on animals, replacing degenerated cells with new ones created from embryonic stem cells. The trials have been successful. While the therapy may not be available for six or seven years, it is encouraging that Pfizer, the world’s largest pharmaceutical research company, will produce the artificial membranes on which the embryonic stem cells are placed. Also it appears the treatment may take less than an hour as an outpatient procedure.

For more information go to:www.maculardegenerationassociation.org

Wednesday, September 2, 2009

Acucela to Present at the Rodman & Renshaw 11th Annual Healthcare Conference

Acucela, a clinical-stage biotechnology company focused on developing new treatments for blinding eye diseases, announced today that Ryo Kubota, M.D., Ph.D., Acucela’s chairman, president and chief executive officer, will present a company update at the Rodman & Renshaw 11th Annual Healthcare Conference.



The presentation is scheduled for 4:55 p.m. EDT on Wednesday, September 9, 2009 at the New York Palace Hotel in New York City.



“We look forward to presenting an overview of Acucela and more details about our recent clinical progress at the Rodman & Renshaw Healthcare Conference,” stated Dr. Kubota. “With the need for effective blinding eye disease treatments becoming even more critical as our population ages, Acucela is developing a new, oral drug therapy for the leading cause of blindness in people over the age of 50, dry age-related macular degeneration (“dry AMD”). We’re excited to discuss how we’re approaching this challenging condition, which affects 26 million people worldwide and for which there is currently no approved treatment.”

About Acucela Inc.

Acucela Inc. is a clinical-stage biotechnology company focused on leveraging promising science in visual cycle modulation (VCM) to develop new methods for treating blinding eye diseases that affect tens of millions of people worldwide. The company’s orally-delivered VCM therapies, which selectively target cells within the retina to protect visual acuity, have the potential to be used to treat several devastating eye diseases, including dry age-related macular degeneration (AMD), retinopathy of prematurity, Stargardt disease and diabetic retinopathy.

Friday, August 28, 2009

Stopping Macular Degeneration

By Margot Kim
NASHVILLE, Tenn. (KFSN) --
It's the leading cause of vision loss for people over 60 -- macular degeneration slowly steals a person's eyesight, making reading, driving and every day living difficult. It's estimated nearly 18 million Americans will have the blinding condition by 2050. Treatment typically involved monthly injections, until now. A new technique could save a person's sight ... along with their time.
Judie Janes' handiwork keeps a long list of friends and family in style. Last year, she thought she made her last stitch.
"I couldn't thread a needle, couldn't see the needle to thread it on my sewing machine," Janes said.
Janes was diagnosed with wet macular degeneration. Abnormal blood vessels growing under her retina were bleeding.
"Vision is not something you can take for granted," Janes said.
Traditionally, doctors inject a drug into the eye that stops the vessels from growing, but it doesn't last.
"It's a big impact on lifestyle for the patients," Peter Sonkin, M.D., a retina specialist at Baptist Hospital in Nashville, Tenn., told Ivanhoe. "They have to come in once a month, sometimes for a year or two or longer."
In a clinical trial, doctors use a small probe that delivers targeted low-dose radiation to the eye. The goal -- damage abnormal the blood vessels without affecting the healthy parts of the eye.
"The amount of radiation exposure to the body from going through this procedure is less than one would get flying from New York to Los Angeles in a plane," Carl Awh, M.D., also a retina specialist at Baptist Hospital, told Ivanhoe.
Then surgeons inject a dose of the traditional medication. They say the radiation-drug combo is more powerful, lasts longer and could eliminate the need for monthly injections.
"Nothing's blurry," Janes said. "I passed the eye test, and you know you can't fake an eye test."
Janes checks her vision every morning. She went from nearly legally blind -- 20/100 -- to 20/20 after surgery.
"Every morning after I do my little grid test, I look at that prayer and it lets me know how blessed I really am," she said.
A grandma who has too much going on to spend her golden years in the dark.
Patients are sedated for the outpatient surgery which takes about an hour. The technique is in the final stages of approval in Europe and should be available there in August. If the trial is successful in the U.S., the treatment could be available in less than two years.

Tuesday, August 4, 2009

Healthy Life: Macular Degeneration

By Ashley Hinson

Story Created: Aug 4, 2009 at 9:40 AM CDT

Story Updated: Aug 4, 2009 at 9:40 AM CDT
BACKGROUND: About 13 million Americans show signs of age-related macular degeneration (AMD), a condition that destroys central vision so things like reading, watching TV and driving are impossible. The condition also robs a person of the ability to see colors and fine detail. Because the U.S. population is expected to age rapidly, cases of AMD are only expected to increase. Middle-aged people have about a 2 percent risk of developing AMD, but this risk increases to almost 30 percent in those over 75 (Source: Emory Healthcare).
There are two types of AMD: wet and dry. Wet AMD occurs abnormal blood vessels behind the retina start to grow under the macula, the central part of the retina. Those blood vessels then leak blood and fluid that cause the macula to bulge outward. Symptoms of wet AMD often develop quickly and include seeing straight lines as wavy. Dry AMD happens when light-sensitive cells in the macula break down and blur central vision. The most common symptom of dry AMD is slightly blurred vision. The condition develops slowly.
TREATMENT: According the American Health Assistance Foundation, currently there is no treatment or cure for dry macular degeneration. However, taking a specific high-dose formula of vitamins and mineral supplements called the AREDS formula has been shown to significantly reduce the risk of progressing from intermediate to advanced or wet macular degeneration. Treatments for wet macular degeneration include drugs called angiogenesis inhibitors (Lucentis, Macugen); photocoagulation, which involves using a high-energy laser to destroy leaking blood vessels; and photodynamic therapy.
RELEARNING TO SEE: Doctors at Emory Eye Center in Atlanta, Ga., are working on a unique form of treatment for AMD that takes advantage of the brain's ability to reorganize itself to make up for vision loss. The therapy involves training AMD patients to focus on using the good cells that remain. "We are encouraging them or influencing them to be able to use those parts of the retina to be able to better utilize the residual vision," Susan Primo, O.D., M.P.H., Director of Low Vision Services at the Emory Eye Center, told Ivanhoe.
In the treatment, doctors first use a computer to map out the areas of the eye that are damaged. The machine then locates the areas that are still sensitive based on factors like thickness of the retina. The computer then uses biofeedback -- in this case a series of beeps that gets faster and louder as the patient moves closer to using the healthiest portion of the eye -- to train the patient to move their eye into the position that gives them the best possible vision.

For more information contact www.maculardegnerationassociation.org

Sunday, April 26, 2009

Nearly 18 Million Will Have Macular Degeneration by 2050

Nearly 18 Million Will Have Macular Degeneration by 2050
By Serena Gordon
HealthDay Reporter

TUESDAY, April 14 (HealthDay News) -- Although the rate of age-related macular degeneration is on the increase, newer treatments could help reduce the most serious effects of the disease by about 35%, new estimates suggest.
Latest Eyesight News

In a study funded by the U.S. Centers for Disease Control and Prevention, researchers report that as many as 9.1 million people will have age-related macular degeneration (AMD) in 2010, but that 17.8 million people will have the potentially blinding eye disease by 2050.

"What we found is that due to aging, the number of cases of early and advanced AMD will increase dramatically no matter what," said study author David Rein, a senior research economist from RTI International in Research Triangle Park, N.C. "In 2050, we project there will be 1.57 million cases of blindness [caused by AMD] with no treatment. But, with vigorous treatment, that number's just about 1 million."

Results of the study are published in the April issue of the Archives of Ophthalmology.

Age-related macular degeneration is a serious eye disease that causes the breakdown of the macula, which is located in the retina. The macula gives you clear central vision, which is essential for reading and driving, even for just seeing people's faces. AMD is a leading cause of vision loss in people over 65, according to the American Academy of Ophthalmologists (AAO).

Risk factors for AMD include advancing age, a family history of the disease, high blood pressure, smoking and obesity, according to the AAO. Though there are treatments that help some people, there is no cure for AMD.

Most of the treatments for AMD are relatively new, only widely available since about 2001, according to Rein. The easiest and cheapest intervention is a special vitamin/mineral combination (vitamins C, E, beta carotene, zinc and copper) that may slow the progression of AMD. This treatment only costs about $100 per year, and when used early in the disease can "reduce vision-threatening disease by 25%," Rein noted.

Other possible treatments include anti-vascular endothelial growth factor (anti-VEGF), which slows the growth of leaking blood vessels in the eyes, laser therapy or photodynamic therapy (PDT), which combines the use of medication and laser therapy to reduce blood vessel leakage in the eyes.

Using a statistical model, the researchers estimated that the rate of visual impairment would drop by 2.4% if everyone with AMD were treated with PDT alone, but by 22% if PDT was combined with vitamin treatments. If, in the future, everyone were treated with laser therapy and anti-VEGF, visual impairment and blindness from AMD would decrease by 16.9%, and the final scenario -- early vitamin treatment and laser therapy -- would reduce serious visual problems in AMD by 34.5%.

"Age-related macular degeneration is a major public health problem, and as people are living longer, more people are going to develop some form of macular degeneration," said Dr. Alexander Aizman, a clinical instructor in the department of ophthalmology at New York University School of Medicine in New York City. "The scenarios in this study are very plausible."

Aizman said that although there's currently no specific preventive treatment to avoid AMD altogether, the same things that keep your heart and the rest of your body healthy -- maintaining the proper weight, exercising, not smoking and avoiding secondhand smoke -- can also help keep your eyes healthy.

"If you have a relative who has been diagnosed with AMD, it's important to know that you're probably at a higher risk of AMD than the general population," said Aizman. "If you're 60 or older, have regular eye checkups with an ophthalmologist or a retinal specialist to find out if you have any early changes that suggest AMD."

SOURCES: David Rein, Ph.D., senior research economist, RTI International, Research Triangle Park, N.C.; Alexander Aizman, M.D., clinical instructor, department of ophthalmology, New York University School of Medicine, New York City; April 2009, Archives of Ophthalmology

Sunday, April 19, 2009

Stem cell treatment for sight loss could be in use by 2012

Stem cell treatment for sight loss could be in use by 2012

Published Date: 13 April 2009
By LYNDSAY MOSS, HEALTH CORRESPONDENT
A STEM cell treatment for the leading cause of sight loss in older people could be in widespread use within six years, according to researchers.
The Edinburgh Science Festival will later this week hear that scientists want to start patient trials of the treatment for age-related macular degeneration (AMD) by 2012.

The work will be discussed at an event looking at drugs to treat people over 65, whose numbers are growing as better health and new treatments mean people are living for longer.

Researchers at University College London are currently working on a treatment using embryonic stem cells to replace the cells lost in the eyes of people with AMD. The condition comes in two forms – known as dry and wet – but treatment currently only exists for the wet form, and this is expensive.

Professor Peter Coffey, from the Institute of Ophthalmology at UCL, said a quarter of population over 65 had AMD.

"There is a carpet of cells at the back of the eye which support the seeing part of the eye, which is the retina.

"That carpet of cells started to degenerate and die, and as a result the person goes blind because the seeing part of the retina no longer has the support that it needs.

"What we are looking at is whether we can put cells back to regenerate that middle layer."

Laboratory tests have so far been encouraging, and the researchers are working towards producing cells suitable for clinical use.

Once regulatory approval is granted, it is hoped a small trial involving about ten patients will begin in 2011-12.

Saturday, April 11, 2009

He's legally blind and a successful hitting coach

He's legally blind and a successful hitting coach

OMAHA, Neb. (AP) -Mark Wetzel can't tell you exactly what his wife or children look like.

He can, however, tell you how to hit a 95 mph fastball.

Even one of baseball's greatest hitters, Hall of Famer Tony Gwynn, has taken the advice of the man known simply as the "blind guy.''

Left legally blind 45 years ago by macular degeneration, the 59-year-old Wetzel has immersed himself in the study of the swing for the last two decades.

His "laboratory,'' as he calls his training facility, is just a few paces from the front door of the home he shares with wife, Judy, on some land on the north edge of Omaha.

Three nights a week and Sunday afternoons, he breaks down the swings of some 50 students, little leaguers to pros who travel a winding road through the woods and turn off on a gravel driveway leading past a fishing pond to the red steel building that houses two batting cages.

Wetzel knows his students' swings, but not their faces.

He prods, encourages, tweaks.

He usually gets results.

Some have compared his logic-defying talent to that of a horse whisperer.

"Guys ask me all the time how he does it. I tell them I have no idea,'' said Matt Macri, who became Wetzel's first pupil to reach the majors when he appeared in 18 games for the Minnesota Twins last year.

Macular degeneration blurs the center of the field of vision, but Wetzel is able to use his peripheral vision to see shapes and outlines. "That's where I live,'' he said.

Wetzel said when he looks straight ahead, he can see two fingers held 2 feet from his face, but the view is cloudy.

Instead of looking directly at the batter he's instructing, he turns his head and watches him out of the corner of his eye.

"I can tell where the knob of the bat is, and I know exactly what your elbow is doing and where your head is going to go next,'' Wetzel said. "I see that outline, and I connect all the dots.

"You take your great running backs and point guards, and they have great peripheral vision. I'm not so sure they don't see the body move in a different way than the average person does. You can almost see the body move before the body goes there.''

Of course, there are those who condescend or doubt that a blind man could really teach hitting.

The folksy, self-deprecating Wetzel brushes it off.

Asked why he teaches hitting, he says, "Well, do you think I should teach catching? I'm only good for two or three knocks to the head a day.''

Wetzel said he took to heart his grandfather's lectures about not allowing blindness to stop him from doing what he wants.

So he yuks it up about the days he drove a truck for the portable-toilet business he once owned. That's right. He drove, but not for the last 15 years. And don't ask whether he had a license.

"I would go to great lengths to never turn left. That meant you had to turn against traffic,'' he said, letting out a big laugh.

He also used to be a hunting guide, but he had to quit that when he couldn't see birds' silhouettes against the sky anymore.

Baseball was his boyhood passion, and it remains so. He makes a living charging $90 for a one-hour lesson.

He is, to be sure, doing what he wants.

He points out that he's had eight of his players drafted the past six years, and some 30 have gone on to Division I college baseball since he started teaching 22 years ago.

"It's a little bit unorthodox because of his vision problems,'' said Gwynn, who became coach at San Diego State after retiring from the Padres in 2001. "He gets right in there, and he totally gets it.''

Wetzel holds once- or twice-a-month gabfests on the phone about the batter's art with Gwynn and former major league hitting coach Merv Rettenmund. Wetzel met both through a friend, Omaha native and former Padres pitching coach Dan Worthen, who's now with the New York Mets.

Wetzel earned Gwynn's respect shortly after they met about 10 years ago. Wetzel was visiting with him in the dugout before a Padres' game in St. Louis, and the conversation turned to Gwynn's swing.

Wetzel pointed out a flaw, something about the way Gwynn was pushing off with his back foot.

A career .338 hitter and winner of eight National League batting titles, Gwynn was stunned.

"Major league hitters have egos, and my first thought was, 'Who is this blind guy to tell me what I'm doing wrong?' " Gwynn recalled.

Gwynn said he thought about what Wetzel said, and discovered Wetzel was right.

"I decided to go to work on it, and I got it fixed,'' he said.

Wetzel first had trouble seeing when he was 11. He was a good ballplayer, but he started misjudging flies in the outfield and striking out.

He was legally blind three years later. His playing days were over.

He worked a variety of jobs as he got older. There were the portable-toilet and hunting-guide businesses, and he trained dogs and operated a kennel.

Baseball came back into his life when his son, Lance, started playing in the 1980s.

Wetzel wanted to help out with Lance's team but was shooed away.

"They wanted to put me on (soda) pop duty, or help the moms line up the snacks for after the games,'' he said.

Despite his blindness, he thought he could teach hitting better than Lance's coaches. He would watch instructional videos by sitting with his nose pressed up against the TV. Within a year or two, fathers started to bring their sons to see the blind guy.

Wetzel has come up with a philosophy that places a premium on the batter's ability to relax. Without prompting, he talks about shifting weight to the front of the feet through incremental chin movements. He touts the "million-dollar inch,'' referring to the front elbow's alignment over the belly button, and the importance of "centering the ball.''

"When I was a player, and even when I was coaching, I never thought anyone could teach hitting unless he had done it himself,'' Rettenmund said. "Mark Wetzel proved me wrong.''

Wetzel's students come from near and far. Macri, who grew up 130 miles away in Des Moines, Iowa, started taking lessons from Wetzel 10 years ago when he was a high school freshman. Macri lives in Chicago in the offseason, but still makes it to Wetzel's "laboratory'' once or twice a winter.

A new student, 9 years old, comes in from Kearney, about 180 miles away.

"I think the good lord,'' Wetzel said, "has given me a gift.''

Sunday, April 5, 2009

Zebra fish used to study blindness

Zebra fish used to study blindness
Published: April 3, 2009 at 12:14 PM

WEST LAYFAYETTE, Ind., April 3 (UPI) -- Experiments with zebra fish are helping identify genes linked to retinal diseases that cause blindness, a Purdue University scientist said.

"Once we know the genetic network that influences retinal development, we can begin to understand the changes in specific genes that lead to vision loss," Yuk Fai Leung said.

With such information, treatments could be developed to prevent or reverse diseases such as macular degeneration and diabetic retinopathy, he said.

Using zebra fish, which are closer to humans in eye development than mice or other animal models, a Purdue team developed a new analysis method for analyzing key genes linked to retinal development.

The method can examine thousands of genes and analyze several experimental changes simultaneously, allowing scientists to understand how one change leads to another in degenerative diseases, Leung said.

Retinal degenerative diseases are some of the leading causes of blindness and low vision in an estimated 3.3 million people age 40 and older in the United States, the National Eye Institute said.

Monday, March 30, 2009

FDA Panel to Review Sci-Fi Device for AMD

FDA Panel to Review Sci-Fi Device for AMD
By Emily P. Walker, Washington Correspondent, MedPage Today
Published: March 27, 2009
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine. Click here to rate this report
GAITHERSBURG, Md., March 27 -- An FDA advisory committee may recommend today that patients with macular degeneration have access to a technology straight out of the 1970s TV show, The Six Million Dollar Man.

On tap for the Ophthalmic Devices Panel is a miniature telescope that is implanted in the eye. On television, it gave Steve Austin super-long-range vision.

But the real-life product up for premarket approval won't play a role in covert government operations -- it's intended to improve the eyesight of elderly people with macular degeneration.

Called the Implantable Miniature Telescope, the device is made by Vision Care Ophthalmic Technologies, which wants to market it for patients who are 65 or older with stable moderate to profound vision impairment caused by bilateral central scotomas associated with end-stage age-related macular degeneration.

The device directs light from the lens onto still-functioning portions of the macula to maintain central sight. It increases vision up to about three meters, helping patients to read and perform other close-up tasks, though doing nothing for their ability to drive.

The device would be implanted in one eye. Because it only improves central vision, implant recipients would rely on the opposite eye for peripheral sight.

The application calls for the device to be implanted by cornea specialists who are trained by Vision Care.

This is the second time the company has sought FDA approval for the device.

The panel voted against recommending approval in 2006, saying there was not enough proof the telescope was effective and too much evidence that it was not safe.

Most concerning to the 2006 panel was higher-than-expected cell loss in the implanted eye.

Since then, the sponsor has submitted longer-term data showing the telescope improves central vision. But the studies also showed that the benefit decreases over time.

Also since the last meeting, there have been an additional seven reports of late-occurring corneal edema. Ten of the 13 total cases of corneal edema were observed two years after surgery.

In addition, more cases of corneal decompensation have turned up in the long-term data.

For the original study, researchers implanted one of two versions of the telescope in 206 patients with incurable central vision disorders and who were over 55 and had a need for cataract surgery.

To be eligible for the trial, patients needed to have "best corrected distance visual acuity" between 20/80 and 20/800, and have adequate peripheral vision in the nonimplanted eye.

The primary endpoint for efficacy was improvement of two lines or greater in either near or distance vision, which was achieved in 86% of patients at follow-up.

But the data indicated that the longer the telescope stays in place, the effectiveness diminishes slightly.

For instance, at 12 months, 90% of patients had two lines of improved vision in either near or distance vision, but at 24 months, that number dropped to 86% (P<0.001 for both).

At 12 months, 73% of patients had improvements in both near and distance vision simultaneously. At two years, that percentage dropped to 67% of patients.

In a four-year follow-up that the company completed at the request of the FDA, just 68% of the patients achieved a two-line or greater gain in either long distance or near vision four years after the surgery.

Eyes with profound vision impairment showed a more significant improvement compared with those with moderate vision impairment, which was sustained throughout the entire study period.

During the study, five eyes lost more than two lines of vision, and eight devices were eventually removed because of patient dissatisfaction.

The panel, which is chaired by Jayne Weiss, M.D., an ophthalmologist from the Kresge Eye Institute in Detroit, will decide whether the new data provide reasonable assurance of an acceptable long-term risk of corneal decompensation.

The panel will also decide whether the sponsor took into account the improvement in vision after cataract removal without telescope implantation.

Saturday, March 21, 2009

Details of age-related blindness may be obtained from 3-D snapshots of eyes

Details of age-related blindness may be obtained from 3-D snapshots of eyes

March 20th, 2009 - 11:27 am ICT by ANI -

Washington, March 20 (ANI): A group of U.S. scientists have created ultra-detailed 3-D images of the eyes of more than 2,000 people from different ethnic groups, 400 of whom have age-related macular degeneration (AMD), hoping that they will pave the way for new diagnostic software that will help get a better look at the abnormalities that cause this condition, and prove useful for developing new treatments.
The team was led by James Fujimoto at the Massachusetts Institute of Technology and collaborators Jay Duker of the Tufts University School of Medicine, and Joel Schuman of the University of Pittsburgh School of Medicine.
AMD is a condition in which the macula, the region of highest visual acuity in the retina, stops functioning properly. No treatment currently exists for dry AMD, and those available for the wet form can only slow, not stop, vision loss.
The researchers say that publishing the electronic data in 3-D images may make it available to the image processing community to develop computer programs that can quickly and automatically detect the details and severity of the disease.
Fujimoto admits that developing such a program will be difficult because of the sheer quantity of data contained in each data set.
He, however, insists that this data is important because quantitative measurements can be used to track disease progression, and help establish correlations between the severity of vision loss and changes in the architecture of the eye.
A report on the research teams work has been published in the journal Optics Express. (ANI)

Saturday, March 14, 2009

New Test for Early Detection of MD

Mar 10, 2009 07:00 ET
Revolutionary Genetic Test Now Available for Age-Related Macular Degeneration
For the first time ever, an individual's inherent risk of developing this devastating eye disease can be determined
TORONTO, ONTARIO--(Marketwire - March 10, 2009) - ArcticDx Inc., a molecular diagnostic company with expertise in the design, development and commercialization of validated molecular diagnostic tests, announced today the availability of a test specifically designed to determine one's inherited risk for Age-Related Macular Degeneration ("AMD").
AMD is the leading cause of late onset visual impairment and legal blindness in the western world among people over the age of 50. According to reports from the AMD Alliance International and the Foundation for Fighting Blindness, more people have AMD than breast cancer, prostate cancer, Parkinson's and Alzheimer's disease combined. Over 15 million people in North America are currently affected by AMD and experts estimate that, as the population ages, the number of those afflicted will double by the year 2020.
AMD is a progressive disease associated with aging that causes damage to the macula - the light-sensitive cells at the center of the retina at the back of the eye. The macula is responsible for our ability to see with enough detail to read, drive, watch television and perform other activities that require focused, straight-ahead vision, as well as providing information that allows us to perceive colors. Once significant vision is lost, it cannot be restored and, if untreated, AMD will ultimately lead to blindness.
Seventy-five to eighty percent of all AMD has been traced to genes inherited from family members. Until recently, there was no opportunity to determine who may carry these genes or be at risk. The test, Macula Risk(R), changes that. It was developed by a leading geneticist, Dr. Brent Zanke, (Chairman and Chief Medical Officer of ArcticDx) in collaboration with an international group of independent research scientists. Analytical studies have shown this test to be 100% accurate in identifying the AMD genes.
Macula Risk(R) is now available as a CLIA-certified laboratory saliva test to anyone who is concerned about a family member or themselves. It is recommended that adults be tested once in their lifetime. Knowing the risk and accessing appropriate care may save the vision of countless individuals who otherwise would not have taken necessary action until it was too late. Individuals with a diagnosed drusen (early AMD) should check with their eye care professional to see if the test is right for them.
Dr. David Chow, a world-renowned retinal specialist practicing at St. Michael's Hospital, Toronto, commented, "Macula Risk(R) will identify patients at risk so they can be diligently monitored as their disease progresses. Early detection has the potential of significantly improving the final visual outcome of these patients who will develop advanced AMD. The efficacy of treatments like ranibizumab is greater for patients detected earlier with higher baseline visual acuity and smaller lesions."
"Individuals with a family history of AMD may themselves have early signs of the disease and not yet know it," commented Dr. Zanke. "For those with early disease, Macula Risk(R) will tell them if they are likely to progress to vision loss so they can seek professional support from an eyecare professional."
ArcticDx will introduce the test in Canada through the Company's exclusive Canadian distribution partner, Clarion Medical Technologies of Cambridge, Ontario. In the U.S., ArcticDx Inc. will introduce the testing service directly. The company has engaged a team of US vitreo-retinal medical advisors along with Dr. David Chow, Chairman. They include Dr. Carl Awh (Tennessee Retina), Dr. Tarek Hassan (Associated Retinal Consultants, Michigan), Dr. Phillip Ferrone (Long Island VitreoRetinal Associates, New York), Dr. Pravin Dugel (Retinal Consultants of Arizona) and Dr. Peter Kaiser (Cole Eye Institute, Cleveland Clinic, Ohio).

Wednesday, February 25, 2009

Cataract Surgery Doesn't Worsen AMD

Study says surgical advances may explain away the link seen in earlier research

Robert Preidt

THURSDAY, Feb. 5 (HealthDay News) -- Cataract surgery doesn't hasten vision loss in people with age-related macular degeneration (AMD).

That's the conclusion of a new study that challenges the findings of several large epidemiological studies that suggested a link between cataract surgery and accelerated AMD progression.

AMD and cataracts are leading causes of vision impairment in the United States. Both are related to aging and share other risk factors. AMD affects the retina and leads to loss of central vision. Cataract is cloudiness in the eye's lens that interferes with clear vision.

For the new study, Dr. Emily Y. Chew, of the U.S. National Eye Institute, and colleagues analyzed data from 4,577 participants (8,050 eyes), ages 55 to 81, who took part in the Age-Related Eye Disease Study (AREDS). The researchers compared the risk of advanced age-related macular degeneration in people who had surgery to remove cataracts and in those who didn't have the surgery.

Chew and her team found little evidence that cataract surgery influences AMD progression. The study was published in the February issue of the journal Ophthalmology.

"These data may provide some reassurance to patients with AMD who are considering cataract surgery," Chew said in an American Academy of Ophthalmology news release.

Several possible factors may explain the conflicting conclusions of this new study and previous population-based research, Chew said. The most likely factor is that earlier studies may have had unintended biases or confounding variables. Chew also noted that cataract surgery and lens replacement techniques have advanced, and the AREDS participants' procedures were performed more recently than people included in earlier studies.

Tuesday, February 17, 2009

Hope For Macular Degeneration Patients

By Donna Willis
Web Content Coordinator
Published: February 16, 2009

CENTRAL OHIO—A groundbreaking surgery here in Columbus promised new hope in the treatment of the No. 1 cause of adult blindness.

NBC 4’s Colleen Marshall GETS TO THE HEART OF THE MATTER.

Macular degeneration blinded 500,000 Americans last year, and that number was expected to double during the next five years.

Macular degeneration is a breakdown in the blood vessels in the retina, the tissue lining of the eye, and is caused by the same things that cause heart problems: fatty diets, high blood pressure, sedentary lifestyle, age, obesity and heredity.

The Retina Group, in Downtown, was set be the first in the Midwest or East to surgically insert medicine to the back of the eye through a new catheter system.

The surgery was scheduled for Tuesday morning.

“In between the retina and the sclera, which is the white part of the eye, we pass the catheter all the way back directly to where those abnormal blood vessels are, and we deliver the medicine,“ Dr. Michael Samuel said. Samuel is with The Retina Group.

“This is supposed to relieve me for six to eight months of having to have that needle in the eyeball, which would be heaven,“ said patient Mary Thompson.

Thompson was diagnosed with macular degeneration four years ago.

It was thought the new surgery could provide a cure for some people.

nbc4i.com—Where Accuracy Matters.

Thursday, February 12, 2009

Vigorous exercise may prevent vision loss

There’s another reason to dust off those running shoes. Vigorous exercise may help prevent vision loss, according to a pair of studies from the U.S. Department of Energy’s Lawrence Berkeley National Laboratory.

The studies tracked approximately 31,000 runners for more than seven years, and found that running reduced the risk of both cataracts and age-related macular degeneration.

The research, which is among the first to suggest that vigorous exercise may help prevent vision loss, offers hope for people seeking to fend off the onset of eye disease.

“In addition to obtaining regular eye exams, people can take a more active role in preserving their vision,” says Paul Williams, an epidemiologist in Berkeley Lab’s Life Sciences Division who conducted the research. “The studies suggest that people can perhaps lessen their risk for these diseases by taking part in a fitness regimen that includes vigorous exercise.”

A cataract, which is a cloudy opacity of the eye lens, is the leading cause of blindness. More than one-half of people in the U.S. over the age of 65 suffer from some form of cataracts. Age-related macular degeneration, which is damage to the retina, is the leading cause of irreversible vision loss in older white Americans, affecting 28 percent of people aged 75 and older.

The diseases have several known risk factors, such as sunlight exposure and diabetes in the case of cataracts, but few interventions. Now, it appears that vigorous cardiovascular exercise may be one way to derail the diseases.

To conduct the research, Williams analyzed data collected in the National Runners’ Health Study, which he established in 1991 to determine the health benefits of running.

In this case, he followed approximately 29,000 male runners and 12,000 female runners for more than seven years. Of these people, 733 men reported being diagnosed with cataracts on a questionnaire filled out at the end of the study. Too few women reported cataracts to track.

Men who ran more than 5.7 miles per day had a 35 percent lower risk of developing cataracts than men who ran less than 1.4 miles per day. The study also analyzed men’s 10-kilometer race performances, which is a good indicator of overall fitness. The fittest men boasted one-half the risk of developing cataracts compared to the least-fit men.

A second study found that running appeared to reduce the risk of age-related macular degeneration. In the study, 152 men and women reported being diagnosed with the disease. Compared to people who ran less than 1.2 miles per day, people who averaged between 1.2 and 2.4 miles per day had a 19 percent lower risk for the disease, and people who ran more than 2.4 miles per day had between 42 percent and 54 percent lower risk of the disease.

“These findings are compelling because of the large size of the study, and the fact that we are looking at something that is fairly well defined: vigorous exercise, as opposed to more moderate exercise,” says Williams.

Most of the runners in the study exceeded the current public health recommendations for physical activity, which is at least 30 minutes of moderate-intensity activities such as brisk walking five days a week, or smaller doses of more vigorous exercise such as running. It is unclear whether people might also lower their risk for cataracts and age-related macular degeneration by walking.

“We know there are important health benefits to walking, including lowering heart disease risk,” says Williams. “It is quite likely that the studies’ results might apply to a lesser extent to smaller doses of more moderate exercise.”

Williams also adds that further research is needed to explore why there is a link between vigorous exercise and a decreased risk for eye disease.

“We know some of the physiological benefits of exercise, and we know about the physiological background of these diseases, so we need to better understand where there’s an overlap,” says Williams.

The studies are published in the January 2009 issue of Investigative Ophthalmology and Visual Science. They were supported in part by grants from the National Heart Lung and Blood Institute.

Berkeley Lab is a U.S. Department of Energy national laboratory located in Berkeley, California. It conducts unclassified scientific research and is managed by the University of California. Visit our website at http://www.lbl.gov.
Additional information:

* More information on Williams’ research can be found at http://healthresearch.lbl.gov.

Thursday, February 5, 2009

Ghostly faces and visions of 'little people': The eye disorder that leaves thousands of Britons fearing they've lost their senses

By Morag Preston
Last updated at 8:06 AM on 03rd February 2009

Following his wife's death six years ago, David Stannard has become accustomed to spending quiet evenings alone at his home in Walton-on-Thames, Surrey.

So it came as a surprise to the 73-year-old when he looked up from his television one evening to discover he was sharing his living room with two RAF pilots and a schoolboy.

'The pilots were standing next to the TV, watching it as if they were in the wings of a theatre,' he says.

'The little boy was in a grey, Fifties-style school uniform. He just stood there in the hearth looking puzzled. He was 18 inches high at most.'

Mr Stannard's guests never said a word and vanished after 15 minutes. That night, he says, the walls of his house, which had always been white, looked as though they had been redecorated in patterned wallpaper with a brickwork effect.

The next morning he was caught off-guard again when he found a fair-haired girl standing on his sofa. She also appeared to be from the Fifties, but was life-size, wearing a short skirt and pink cardigan, with chubby knees, white ankle socks and ribbons in her hair.

'I watched her for a while,' he says. 'She didn't move much. Then she was gone.'

It would be easy to dismiss Mr Stannard's story as the bizarre imaginings of an elderly mind. Fortunately, he knew he wasn't losing his mind; neither was his house haunted.

A few weeks earlier he had been registered blind, though he was still able to watch television if he sat at a certain angle. He'd been warned that as his eyesight deteriorated, he might experience visual hallucinations in the form of Charles Bonnet Syndrome (CBS).

'I was lucky enough to know what it was,' he says, 'otherwise I would have thought I was going bonkers.'

An estimated 100,000 people in Britain have Charles Bonnet Syndrome (CBS), which leads to hallucinations. These can include visions of miniature people.

An estimated 100,000 people in the UK have CBS, but many won't realise it because the condition remains something of a mystery.

The real number is probably higher because sufferers are often too ashamed to talk about what they have seen for fear of being considered crazy.

The late historian Lord Dacre of Glanton, formerly Hugh Trevor-Roper, was unusual among CBS patients in that he talked openly about what he jokingly referred to as his 'phantasmagoria'.

He would see horses and bicycles racing, and whole landscapes whizzing by as if he were on a train. On one occasion, he found himself trapped in an apparently endless tunnel.

Hallucinations tend to have common themes: simple geometric patterns, disembodied faces with jumbled features, landscapes, groups of people, musical notes, vehicles and miniature figures in Victorian or Edwardian costume. They can be in black and white or colour, moving or still, but they are always silent.

The condition was named after Charles Bonnet, an 18th-century Swiss natural philosopher whose grandfather had seen people, patterns and vehicles that were not really there. Bonnet was the first person to identify that you could have visual hallucinations and still be mentally sound.

The condition can affect anybody at any age with diminishing eyesight. Even people with normal vision can develop it if they blindfold themselves for long enough.

But most people who have CBS have it as a side-effect of age-related macular degeneration - the most common cause of blindness in the UK. It is thought that up to 60 per cent of patients with severe vision loss develop CBS.

Crucially, CBS is caused by lack of visual stimulation rather than mental dysfunction.

Usually, on opening our eyes, the nerve cells in the retina send a constant stream of impulses to the visual parts of the brain. If the retina is damaged, the stream of impulses reduces, but - rather than lie dormant - other parts of the brain become hyperactive.

So when the brain isn't receiving as many pictures as it is used to, it builds its own artificial images instead from the areas we use every day to process faces, objects, landscapes and colours.

What you hallucinate depends on which part of the brain these increases are located. But why only a proportion of patients with macular degeneration experience hallucinations is still unknown, or why younger patients with macular degeneration are less likely to have CBS than older ones.

Dr Dominic ffytche, a senior lecturer at the Institute of Psychiatry, is a leading expert on CBS. He has been at the forefront of a campaign led by the Royal College of Ophthalmologists and The Macular Disease Society calling for eye doctors to warn patients with macular degeneration that they may develop CBS.

He says: 'In our experience, forewarning and knowledge of the possibility of hallucinations helps patients cope when they occur. It allows them to realise this indicates a functional problem with their sight and not a problem with their mind.'

It is thought that stimulating the fingertips, for example by feeling a dice with dimples, can help sufferers of CBS stop experiencing hallucinations.

In 2003, Sandra Jones, 54, a former TV producer, thought she was losing her mind when she started seeing faces looming towards her out of nowhere.

Having visited various massacre sites, including Rwanda, as part of her job, she assumed it was a form of post-traumatic stress disorder.

'Part of me thought this was payback time,' she says.

The faces would swirl off the pages of the book she was reading, or appear in front of her computer screen. It would happen three or four times a day, usually when she was feeling relaxed or trying to get to sleep.

'Some nights I couldn't lose them and I would only get an hour's sleep,' she says. 'Closing my eyes wouldn't help, so I'd get up and clean my house just to keep moving. I got the feeling that if I was tired, it would help me fall asleep, which would then free up my mind.'

She didn't dare tell friends or anyone at work for fear of jeopardising her job, and found out about CBS only after researching her symptoms online. Earlier that year she had been diagnosed with Sorsby's fundus dystrophy, a rare genetic eye condition which causes early onset macular degeneration, but nobody had warned her that hallucinations might be a side-effect.

'The unpleasant feeling was of not being in control,' she says. 'Once they are identified, they are not a problem.'

If the retina is damaged, the stream of impulses reduces and other parts of the brain become hyperactive.

Hallucinations can last from only a few seconds to several hours. In a minority of unlucky cases, they are continuous throughout the day. Patients usually have several daily before they taper off to once a week, then once a month.

For 60 per cent of patients, they will stop entirely after 18 months. There has not yet been a long-term study, but some patients report having them for at least three years.

Part of Dr ffytche's research involves looking into ways patients can stop the hallucinations. 'There won't be a single recipe for everyone,' he says. 'But hallucinations tend to occur when you are in a state of drowsy wakefulness, so you want to rouse yourself.'

As the condition is caused by a lack of stimulation in the visual part of the brain, one of the techniques he is investigating is stimulating the fingertips.

This is based on the fact that studies of brain scans of sight-impaired people reading Braille show increased activity in that area. The theory is that even feeling a dice with dimples could bring visions to a halt.

Other techniques include holding your breath; turning on a light if it is off, or vice-versa; standing up if you are sitting down; and moving your eyes. In extreme cases, medication is used. But the drugs can have side-effects such as tremors, drowsiness, sickness and diarrhoea.

Dr Winfried Amoaku, chairman of the Scientific Committee of the Royal College of Ophthalmologists and a specialist in macular degeneration, says when they come to visit him, patients do two things: first, they request that nobody else is in the room before mentioning the hallucinations, then afterwards they breathe a sigh of relief.

For Mary Orr, 84, from West Kilbride, the final straw was seeing the walls of her house covered in white fur. In desperation, she started to claw at them. 'It was then I thought: "I can't live like this," ' she says.

After months assuming she had dementia, she was referred to a psychiatrist who recognised the signs of CBS straight away and told her to see an eye doctor.

It explains why she still sees pink squares and snakes rising out of the pavement, but Mary is resolute that the worst is behind her. As she says: 'It's the fear of not knowing what's happening that you can't live with.'

• The Macular Disease Society, www.maculardisease.org, 0845 241 2041; Royal National Institute for the Blind, www.rnib.org.uk, 0303 123 9999.

Wednesday, January 28, 2009

Obama Election Called End of 'Sad Chapter' for Science

(BioWorld Today Via Acquire Media NewsEdge) Q&A: Robert Lanza

With the recent swearing in of new President Barack Obama there is much anticipation that the U.S. government will be more supportive of embryonic stem cell (ESC) research. In our first BioWorld Q&A feature, we spoke with Robert Lanza, chief scientific officer of Advanced Cell Technology and chief scientific advisor for Worcester, Mass.-based International Stem Cell & Regenerative Medicine International, a recently formed joint venture between ACT and CHA Biotech.

BioWorld: Why was this joint venture created?

Lanza: It will initially develop human blood cells and other clinical therapies based on ACTC's proprietary hemangioblast cell technology. It holds the exclusive license to all of ACT's hemangioblast technology. It is anticipated that this technology may some day help address the critical care shortage of blood for emergency situations, including military needs. The technology also has been shown to repair vascular damage in animals after heart attacks, limb ischemia and diabetes.

BioWorld: What are the major issues facing stem cell researchers today?

Lanza: One of the major issues is the problem of tissue rejection. To date, there is no way to transplant replacement cells derived from ESCs into a patient without powerful immunosuppressive drugs, which of course, are associated with cancer, infection and a long list of other serious side effects. In fact, the need for systemic immunosuppression could make the treatment worse than the disease. This is why we are focusing on "universal" blood, platelets and diseases that involve immune-privileged sites, such as the eye. Another major problem: You need to have a source of cells that is readily available, safe and that can be generated on a large scale. Unfortunately, it turns out that only a few replacement cell types can - at least at present - be reliably generated from hESCs. Assessment of safety and efficacy also are critical before hESC therapies can move into the clinic.

BioWorld: With restrictions on federal funding under President Bush, many researchers headed overseas and there was concern that the U.S. was losing talent and momentum. Do you see this changing under President Obama?

Lanza: Yes, all of this will change under President Obama. His inauguration marks the end of a sad chapter in American scientific history - where laws were passed that actually criminalized scientific research. As you know, the Bush administration has had an adversarial relationship with the scientific community (bordering on being antiscience). The new U.S. leadership (both the White House and Congress) will hopefully now listen to advice from the medical and scientific community (rather than taking sides in religious debates). The black cloud that has hovered over stem cell research in the United States has finally been lifted. We have been operating for the last decade with one hand tied behind our back. Under the new Obama administration, money will hopefully flow to all promising avenues of research based on scientific merit (and not skewed to fit a conservative Christian agenda). This extends not only to NIH and SBIR grants, but to NIST and even to DARPA grants. The impact on the private sector is equally critical. The day after Obama was elected, investors started to come out of the woodwork. For instance, we were on the verge of bankruptcy, and did an about-face as soon as Obama was elected.

BioWorld: How far away are we from having meaningful therapies for patients?

Lanza: As far as ESCs, there are really only two companies on the verge of clinical trials - ACT and Geron. We've already had our official Pre-IND meeting with the FDA. They seemed happy with our data and clinical plans. We hope to file an IND to begin clinical trials to prevent blindness by summer. We still have a few studies to complete, but everything looks great so far. Of course, the field desperately needs a big clinical success. We have developed a technology to treat degenerative eye diseases such as macular degeneration. We have demonstrated that these hESC-derived cells can rescue visual function in animals that otherwise would have gone blind.

BioWorld: Last week, Geron became the first company to get FDA approval to begin a Phase I trial of an ESC product, GRNOPC1, to treat patients with spinal cord injury. (See BioWorld Today, Jan. 26, 2009.) Is this a clear sign of things to come for the field?

Lanza: This is a huge advance for the entire field - my hat is off to them. This is what we've all been waiting for. It has been over a decade since ESCs were first discovered. This sends a message that we're ready at last to start helping people. Again, we are planning to file an IND with the FDA to begin clinical trials to prevent blindness this summer. Sometimes, it's the second mouse that gets the cheese. Now that the FDA is comfortable with the safety of ESC therapies, all eyes will be looking for results. That is, can you really treat or cure a disease? Of course, it's extremely important that Geron does well in this trial. It could be a disaster if something goes wrong. Remember what happened with gene therapy. They shut everyone down.

BioWorld: What sort of advantage does your technology offer?

Lanza: In addition to generating "universal" blood, there are also advantages of using retinal cells to treat blindness and eye disease. We have been able to consistently and reliably generate retinal cells - known as "retinal pigment epithelium" (or RPE) - from every hESC line we have studied. These cells have been extensively characterized and have all the markers and behavior of normal retinal cells. The retinal pigment epithelium is an important eye tissue, which plays a critical role in the pathogenesis of macular degeneration, retinitis pigmentosa and other retinal degenerative diseases. In the RCS rat, improvement in visual performance was 100 percent over untreated controls without any apparent adverse effects. In untreated animals, the layer of cells the animals see with was only one layer deep after 100 days. However, in the treated animals, the cells were five-to-seven cells deep! Of course, control sham-treated eyes showed no improvement.

BioWorld Q&A is a periodic feature that profiles industry leaders and particular companies, or serves as a sounding board for a variety of issues. If you have suggestions for a particular subject, send your emails to newsdesk@bioworld.com.