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.

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)

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).