Synexus sets its sights on ophthalmology

SynexusPosted on:25 Oct 10



Synexus is set to take part in a number of global ophthalmology trials following recent investment in clinical research expertise and technology in this area.

Chief Executive, Dr Christophe Berthoux says that ophthalmology offers considerable growth potential for Synexus: “There is significant demand for new ocular drugs, not only for currently untreatable conditions, but also for improved treatments for conditions such as diabetic retinopathy and glaucoma, and this is set to increase the size of the market, making it attractive to more pharma companies. There have been relatively few new drugs brought to market in this area, for example, between 1995 and 2003, there were no new ocular drugs approved by the FDA, and until recently this area of drug development was dominated by only a few companies. Our recent involvement in this field indicates that this is changing and that more companies will be extending their operations into ophthalmology.”

Clinical trials in ophthalmology have historically suffered from a shortage of ophthalmologists with expertise in drug development, and also from the need for investment in expensive screening and diagnostic equipment. Synexus has a proven track record of investing in state-of-the-art technology in order to deliver clinical trials results and also experience of teaming up with leading specialists who work exclusively on their trials. This approach is already proving popular in the ophthalmology field according to Chief Operating Officer, Jane Restorick: “Our expansion earlier this year, with a significantly increased presence in the CEE, puts Synexus in a very strong position to deliver the right patients for ophthalmology trials. Changes in global population demographics, in particular the increasingly ageing population, necessitate the speeding up of ocular drug development, and the need for a greater number of more effective treatments for eye disorders. The way Synexus operates means that we can respond quickly with investment in equipment and in clinical expertise.”

There are an estimated 45 million blind people and 135 million visually impaired people worldwide. Age-related macular degeneration (40%), glaucoma (13%) and diabetic retinopathy (8%) are the three most common causes of visual impairment and blindness. Clinical trials in the ophthalmology area are vital to speed up progress in dealing with serious eye diseases including macular degeneration, diabetic retinopathy, glaucoma and eye herpes.

Eyetech Announces Program to Develop Extended-Release Formulation of Macugen

by mincho2008

Eyetech Inc. announced today a program to develop an extended-release formulation of Macugen® (pegaptanib sodium injection) using microparticles technology. Macugen, a selective inhibitor of VEGF-165, is approved for the treatment of neovascular age-related macular degeneration (neovascular AMD). The goal of the Macugen extended-release formulation is to decrease the frequency of dosing from every six weeks to every four to six months. Eyetech is collaborating with SurModics Pharmaceuticals, Inc., a leading drug delivery company, to develop the extended-release version of Macugen under a licensing and development agreement that was signed in 2005. The development program was announced today at the second annual Ophthalmology Innovation Summit in Chicago.

"An extended-release formulation of Macugen could offer several potential advantages to physicians, patients with neovascular AMD and their families, including a more convenient dosing schedule, improved compliance, and a lower risk of complications related to the injection," said Scott W. Cousins, M.D., project leader for the Macugen Microparticles Program and vice-chair of research in the Department of Ophthalmology at Duke University School of Medicine in Durham, NC. "I look forward to advancing the Microparticles development program."

Neovascular AMD is a chronic condition that requires long-tem treatment. Recent studies evaluating the injection frequency and visual outcomes using anti-VEGF therapies have shown that giving the treatments on an 'as needed' basis leads to under-treatment and significantly less vision gains.(i) In addition, recently published and presented clinical studies have investigated anti-VEGF therapy as a potential treatment for patients with other retina diseases, such as diabetic macular edema (DME) and retinal vein occlusion (RVO). New drug delivery technologies may be of interest to physicians who serve these patient populations.

Mike Atieh, executive chairman of Eyetech Inc., said: "The announcement of the Microparticles program demonstrates our commitment to addressing the needs of the retina community and collaborating to provide safe and effective treatment options for patients suffering from retina disease."

Eyetech Inc. has the worldwide rights to the Macugen Microparticles program.

About Age-Related Macular Degeneration (AMD)
AMD is a chronic, progressive disease of the central portion of the retina called the macula, resulting in the loss of central vision. The most common symptoms are a central blurred or blank spot, distortion of objects or simply blurred vision. Peripheral vision usually remains intact. AMD is classified into two forms: atrophic, referred to as dry AMD, and neovascular or wet AMD.

In neovascular AMD, abnormal blood vessels grow and leak into the macula, resulting in loss of vision. Neovascular AMD is the more severe form of the disease and progresses more rapidly than the dry type. Although it accounts for only about 10-15 percent of all macular degeneration cases, neovascular AMD is responsible for 90 percent of blindness caused by the disease.

About Macugen
Macugen, a selective inhibitor of VEGF-165, is indicated in the United States for the treatment of neovascular age-related macular degeneration (neovascular AMD) and is administered in a 0.3-mg dose once every six weeks by intravitreal injection. Macugen is a pegylated anti-VEGF aptamer, which binds to vascular endothelial growth factor (VEGF). VEGF is a protein that plays a critical role in angiogenesis (the formation of new blood vessels) and increased permeability (leakage from blood vessels), two pathological processes that contribute to the vision loss associated with neovascular AMD.

Eyetech Inc. markets and sells Macugen in the United States and Pfizer Inc. markets and sells Macugen outside of the United States. For full prescribing information about Macugen, please visit http://www.macugen.com/.

Important Safety Information
Macugen is contraindicated in patients with ocular or periocular infections or with known hypersensitivity to pegaptanib sodium or any other excipient of this product.

Safety or efficacy of Macugen beyond two years has not been demonstrated.

Intravitreal injections including those with Macugen have been associated with endophthalmitis. Proper aseptic injection technique -- which includes use of sterile gloves, a sterile drape, and a sterile eyelid speculum (or equivalent) -- should always be utilized when administering Macugen. In addition, patients should be monitored during the week following the injection to permit early treatment, should an infection occur.

Increases in intraocular pressure (IOP) have been seen within 30 minutes of injection with Macugen. Therefore, IOP as well as the perfusion of the optic nerve head should be monitored and managed appropriately.

Rare cases of anaphylaxis/anaphylactoid reactions, including angioedema, have been reported in postmarketing experience following the intravitreal administration procedure.

Serious adverse events related to the injection procedure occurring in less than 1% of intravitreal injections included endophthalmitis, retinal detachment, and iatrogenic traumatic cataract.

Most frequently reported adverse events in patients treated for up to two years were anterior chamber inflammation, blurred vision, cataract, conjunctival hemorrhage, corneal edema, eye discharge, eye irritation, eye pain, hypertension, increased IOP, ocular discomfort, punctate keratitis, reduced visual acuity, visual disturbance, vitreous floaters, and vitreous opacities. These events occurred in approximately 10% to 40% of patients.

About Eyetech Inc.
Eyetech Inc. is a unique, independent 100% employee-owned and operated biotechnology company dedicated exclusively to the treatment of sight-threatening diseases of the retina.

Eye Doctors of Washington, DC Support National Breast Cancer Awareness Month

By Sarah Bryce

Widely known as specialists in LASIK eye surgery in Washington DC, the Eye Doctors of Washington (EDOW) will be switching gears to support another worthy cause on Friday, October 8th, 2010 at 8:00 am. October is National Breast Cancer Awareness Month, and in collaboration with the Kane Show and HOT 99.5, the doctors at EDOW will be hosting an event to collect donations and give away prizes to raise awareness for breast cancer. The doctors say they are looking forward to the effect this campaign will have on the community as a whole, as they join together to support the fight against a disease that is estimated to affect more than 200,000 women in 2010.

This October marks the 26th annual celebration of National Breast Cancer Awareness Month, which is a partnership of national public service organizations and medical professionals striving to promote awareness, education, and empowerment of everyone affected by breast cancer. As specialists focusing on providing their patients with LASIK in Washington DC and other effective vision care treatments, the doctors at EDOW say that supporting their community has always been a priority within their practice, which is why they are celebrating National Breast Cancer Awareness Month. The doctors say their ultimate goal is to improve the lives of their patients, regardless of the cause of their condition, and supporting breast cancer awareness does just that.

Whether performing vision correction procedures or cosmetic enhancements such as Juvederm™ in Washington, DC, the doctors at EDOW say they appreciate the chance to embrace such a worthy cause this October, and believe events like this are extremely important because they make a real difference in the well-being of patients within their community and across the nation.

About EDOW

The Eye Doctors of Washington have been providing high quality eye care for patients in Washington, DC for over 40 years, and was originally founded by a group of professors from the Center for Sight at Georgetown University. They specialize in all types of eye procedures, from routine eye exams, to vision correction procedures and treatment for eye diseases such as macular degeneration and glaucoma, as well as cosmetic procedures such as BOTOX® Cosmetic in Washington DC. All of the ophthalmologists at EDOW are certified by the American Board of Ophthalmology, as well as being fellowship trained in a sub-specialty of eye care. All of the members of EDOW have received scientific and medical awards, serve on a number of advisory boards, and are involved in the advancement of eye care through academic research.

Radio for the Blind on S.C. chopping block

By Carolyn Click
Published: October 03. 2010


COLUMBIA, S.C. — Since she lost her sight four years ago, Margaret Gutman has come to rely on a state-run radio reading program for the blind to provide her with news from the three major South Carolina papers, opinion pieces from local and national commentators, health and gardening news, and the occasional offbeat magazine article.

So when she learned last month that the South Carolina Educational Radio for the Blind, in existence since the 1970s, was set to become another casualty of the state's economic downturn, she was devastated.

“I just think it is cutting out so much of the outside world,” said Gutman, 76, who suffers from wet macular degeneration, a chronic eye disease that causes swift vision loss in the center of a person's field of vision.

Gutman listens “24/7” to the service, she said, often turning on her special receiver late at night when she cannot sleep to hear volunteers read from The State newspaper, The (Charleston) Post and Courier and The Greenville News. Volunteers read local stories, obituaries, op-ed pieces and even the grocery specials — information the sighted skim quickly and take for granted.

Cutting off ‘my outside world'

When you are blind, “You lose your driving privileges ... you lose the ability even to shop, to look at prices on things and to recognize things in grocery stores,” Gutman said Thursday.

“I just feel they are cutting off a big chunk of my life, my outside world to some degree.”

Her husband, retired Air Force Maj. Walter Gutman, already has written to the governor to voice his concern at the loss of the programming — the only service for the blind that focuses on state current events.

James Kirby, commissioner for the S.C. Commission for the Blind, said he understands the pain and frustration of the legally blind South Carolinians who rely on the service, delivered through special receivers tuned to a dedicated sub channel of ETV.

About 5,000 blind residents around the state have the lent receivers in their homes.

But as the agency's budget over the last two years was reduced from $3.9 million to $2.2 million, Kirby said he determined the $120,000 program, run by three staffers with 50 volunteer readers, had to go.

Kirby said he tried to protect the state-funded radio program, along with children's and blind prevention services, even as he worked to make sure there was enough state funding for rehabilitation programs that receive a significant 80-20 federal dollar match.

‘Double whammy'

“When we cut state dollars in those programs, we have a double whammy,” said Kirby, who plans to elicit support in the state Legislature to restore the service.

About four years ago, he noted, Gov. Mark Sanford tried to eliminate the program, an effort that was turned back.

“When we start the budget process in January we are going to seek the restoration of funds,” Kirby said.

That's good news, too, to the 50 volunteers who have contributed a total of 2,700 hours of reading time over the years and believe the program, with its emphasis on volunteers, is about as efficient as any in state government. The local radio programming is supplemented by additional programming.

“In the grand scheme of the state budget this is such a minor amount of money,” said Don Caughman, who has been reading newspaper and magazine articles to his blind listeners for 31 years. “I and other volunteers over the years have given an awful lot of time to give a service that didn't cost the state anything. It's a little bit annoying to me that it gets lumped in with everything else.”

Caughman began volunteering one morning a week before work, then two.

Since his retirement from BellSouth in 2000, he spends three early mornings inside one of the four sound booths at the studio.

“I try to think about people listening as I talk,” Caughman said. “I try to do it with a certain amount of enthusiasm and proper enunciation.”

Don Siebert, a retired University of South Carolina English professor who created a half-hour show “All About Words” for the blind audience, agrees.

“It seems like the defenseless are the first cut,” said Siebert, who like other volunteers had to audition to become a reader. “This isn't the biggest tragedy in the world, obviously, but it is a shame given how little it costs. It's a symptom of this whole climate of cutting, cutting, cutting.”
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Age-Related Macular Degeneration Week Unites Organizations around the World

NEW YORK, Sept. 17 Age-related Macular Degeneration (AMD), which affects more than 10 million older Americans, continues to be the leading cause of vision loss in the United States. The global cost of the disease according to a recent report is estimated at $343 billion, underscoring the need for swift actions to raise awareness of prevention and treatment options.

During this year's AMD Week, which runs from September 18-26,some of the leading eye-care organizations from 25 countries, has issued a call to action to doctors, patients and caregivers through the public awareness campaign "Don't Surrender to AMD."

This is a promising time for patients as preventative measures and effective, timely treatments have the ability to alter the disease tremendously,but macular disease is only as preventable and manageable as people are knowledgeable. Knowing the facts can significantly improve a person's chances of maintaining healthy vision and a better quality of life."

The National Institutes of Health projects the number of AMD diagnoses to double to 20 million by 2020. Losing vision has devastating consequences to an individual's daily life and those affected by the disease often suffer from severe depression and loss of independence.

However, those at-risk and AMD patients can take steps to reduce needless sight loss. AMD can be prevented or slowed down if a person takes action to keep his or her vision healthy. Along with regular eye exams, the first step is a healthy lifestyle (Don't smoke, take exercise, eat healthily and use sunglasses in bright sunlight). Specially formulated vitamins for those affected by the disease may help, and effective clinically-approved treatments are available for the most severe form of AMD.

In addition, low vision rehabilitation and support services can significantly help patients live with the disease and make the most of their remaining vision.

AMD is a disease that we can prevent and manage,we have the ability to save the sight of many Americans each year.

Through its "Don't Surrender to AMD" campaign,has increased public education efforts - which will span across print, radio, and digital media, including an interactive e-card - to inform the public of preventative measures and treatment options that are available in the fight against AMD.

Don't Surrender To Macular Degeneration

By ARA
Aging gracefully can require you to accept certain changes in your body, from gray or thinning hair to skin that's less firm than it was in your youth. But loss of vision shouldn't be on your short list of changes that are an inevitable part of growing older.

If you're older than 50, you should know about your eye health and what you can do to prevent or slow vision loss. Age-related macular degeneration, commonly known as AMD, is the leading cause of vision loss in older adults. AMD affects about 10 million people in the U.S., and that number is projected to double by 2020, according to the National Institutes of Health.

"AMD is a disease that we can prevent and manage," says Dr. Alan Cruess, Chairman of AMD Alliance International's Scientific Advisory Panel. "We have the ability to save the sight of many Americans each year."

AMD is a degenerative disease that affects the macula, the central part of the retina (think of it as your eye's internal projection screen) responsible for clear central vision. There are two types of AMD - "dry" and "wet." The dry form affects 85 to 90 percent of people with AMD and causes varying degrees of vision loss, characterized by a collection of deposits in the macula called drusen. Far less common, but much more serious, wet AMD causes severe vision loss, as abnormal blood vessels grow and leak blood and fluid into the eye.

If you take certain measures to keep your eyes healthy, you can prevent AMD or slow its progress. AMD Alliance International suggests taking the following three steps to help prevent and manage AMD.

1. Get regular eye exams

Everyone older than 50 should get regular eye exams. Most people believe they receive eye exams as often as they should. However, according to a recent AMD Alliance International study, only 63 percent of those at risk and 56 percent of those at high risk for AMD have their eyes checked annually. Routine exams can help identify AMD and other eye problems in their early stages, when many diseases are more easily treatable.

2. Understand the risk factors for AMD

By knowing the risk factors, you can take steps to reduce the chance of getting AMD. Age is the greatest risk factor for AMD - if you are 50 or older, you're at risk of developing the disease. Having a family member with AMD can also increase your risk.

While you cannot control your age or genes, there are other risk factors, including smoking, poor diet, obesity, and having high blood pressure, that are controllable.

Quitting smoking reduces your risk for AMD. Numerous studies have demonstrated that people who smoke are between two and five and a half times more likely to develop AMD than people who do not smoke.

Studies also suggest that AMD is linked to diets high in saturated fat. Reducing saturated fat consumption and eating more fresh fruits and dark green, leafy vegetables - all foods that are rich in vitamins C and E, selenium and carotenoids - may delay the onset or reduce the severity of AMD. Fish rich in omega-3 fats, like salmon, tuna or mackerel, may also slow the progress of AMD when eaten two to three times a week, according to a study published in the British Journal of Ophthalmology.

3. Ask questions and know your treatment options

If you have been diagnosed with AMD, your ability to ask the right questions and receive accurate information is crucial. Review "Questions to Ask Your Eye Care Professional" at www.amdalliance.org to help guide the conversation at your next eye exam. Be sure you know your exact diagnosis and all available treatment options.

Specially formulated vitamins can reduce the risk of advanced AMD for some patients. Effective, clinically approved treatments are also available for the most severe form of AMD, which may reverse some vision loss. Make sure you ask your doctor about your options and understand what treatment you are receiving.

People living with macular disease should be able to fully participate in choosing their treatment and healthcare options. Know your rights and download the Patient Charter.

Also, if you're diagnosed with AMD, a low vision rehabilitation specialist can help you use your remaining sight to its full potential through special techniques and low vision aids.

Age-related macular degeneration and the loss of vision can be prevented and slowed down. By learning about the disease and making healthy lifestyle choices, many Americans will be able to enjoy healthy vision well into their golden years.

Summer Eye-Care Tips: How to Protect Your Peepers !

by Lisa Martin on September 3, 2010

With September upon us, it may be hard to remember that we still need to use sun protection. With temperatures still summer-like, you still need to protect yourself, your skin, and even your eyes from the harmful rays of the sun.

Often times, eye protection tends gets overlooked while you are lathering on the sunscreen and making sure you are wearing light cool bamboo clothes. Here are a few tips to protect one of the most important organs of your body:

1. Wear your shades! I know you have heard it before, but ultraviolet rays (UV) are really bad for your eyes. These rays can burn your corneas (the surface of your eyes). UV rays can also lead to the development of cataracts (which cause hazy vision) and age related macular degeneration (which is the leading cause of blindness in older Americans). Preventing such long-term damage is easy – buy sunglasses with labels that clearly state that they protect you from 99% – 100% of UVA and UVB light. You may even consider using wraparound sunglasses to stop the UV rays from entering from the sides of the frame! A dark lens does not necessarily offer UV protection; it must also say it does on the label. My doctor has a rack of sunglasses that do just that. I know when buying from them that I am receiving the best sunglasses for my eyes. If you already wear glasses, you can also purchase prescription sunglasses that do the same thing!
2. Wear a hat! A wide-brimmed hat or cap can further protect you from the sun’s harmful rays especially those that hit the eyes from above your sunglasses. Or course, we would recommend one made from bamboo!
3. Stick with your plan! Even if your daily summer routine varies, it is very important to stick with your regular eye care treatment regimen. Your eye doctor will be able to track any changes that are occurring with your eyes (sometimes before you even notice).
4. Wear your swim goggles! If you swim for sport or even for recreation, make sure that you wear goggles to protect your eyes from waterborne bacteria and swimming pool chemicals.
5. Get adequate rest! Summertime never seems long enough. However, instead of packing a million activities into your summer vacation, try getting a little extra sleep. Rest can refresh your eyes and help them work more efficiently.
6. Don’t smoke! Smoking is a known risk factor for macular degeneration. It has also been linked to the development of cataracts and dry eye syndrome. Just add this to the many reasons why you should quit!
7. Lastly, don’t forget the kids! Kids of all ages – from babies to teens – need to wear UV-protective sunglasses and a hat or visor. As with adults, make sure your child’s sunglasses block out 99% – 100% of UV rays.