In the past, treatments for age-related macular degeneration, the leading cause of blindness in those over 60 in the United States, were limited to slowing down the progression of the disease. Now a new drug, just submitted for approval to the Food and Drug Administration, shows hope of actually restoring lost vision in a substantial number of patients.
At a meeting on January 14 for specialists in the disease, San Francisco-based Genentech, which developed the drug, will release detailed data from a late-stage clinical trial. Preliminary data from that trial show it is in line with an earlier study – in both, 95% of the patients who received the drug showed either stabilized or improved vision. In the earlier study, the vision for over one-third of those who received the higher of two doses of the drug improved by three lines on an eye chart – many of them to the point that they could pass an eye exam for a driver’s license. (Details about visual improvement from the more recent study are scheduled to be announced at the meeting.)
According to Emily Chew, Deputy Director of the Division of Epidemiology and Clinical Research at the National Eye Institute (NEI), which is part of the National Institutes of Health, “This is the first time we actually see vision improvement, and it’s not an insignificant number. [It] is quite remarkable.”
Dawn Kalmar, a Genentech spokesperson, says the company has asked the FDA for a “priority review,” which would mean a six-month review time period instead of 10 months. To bridge the gap until approval, the company is making the treatment available through a 5,000-person study in which all the participants will receive the drug. Kalmar says it will be administered at more than one hundred sites throughout the country.