This tiny prosthesis for people with advanced macular degeneration, the development of which we covered back in 2005, may be approved by the FDA by the end of the year, Scientific American reports.
During a 24-month clinical trial, Colby [Kathryn Colby, ophthalmologist and director of the Joint Clinical Research Center at the Massachusetts Eye and Ear Infirmary in Boston] (and fellow ophthalmologists David Chang of the University of California, San Francisco, Doyle Stulting of Emory University’s Eye Center in Atlanta, and Stephen S. Lane of Associated Eye Care in Stillwater, Minn.) developed and tested a preferred technique for implanting the device to most effectively treat bilateral end-stage macular degeneration, which most commonly afflicts people over the age of 55. The device can treat either form of age-related macular degeneration: the dry stage, where the delicate tissues of the macula become thinned and slowly lose function, or the less common wet stage that’s caused by the growth of abnormal blood vessels behind the macula.
The 206 patients in the study shared a number of characteristics, including stable, untreatable, age-related macular degeneration in both eyes with visual acuity no better than 20/80 but no worse than 20/800, along with good peripheral vision. A year after the trial was completed, 90 percent of patients were able to see two lines better on a reading chart, and 67 percent were able to see three lines better, which is the equivalent of doubling their vision, says Chet Kumar, VisionCare’s director of business and market development.