FDA panel recommends new approval for Genentech eye drug
SILVER SPRING, Md. — A panel of Food and Drug Administration experts is recommending the approval of a drug made by Genentech for diabetic macular edema, the company said.
Genentech, a subsidiary of Swiss drug maker Roche, said the FDA Dermatologic and Ophthalmic Drugs Advisory Committe's 10 members had voted unanimously to recommend approval of Lucentis (ranibizumab) in the 0.3-mg dose for DME, while voting 8-2 to recommend approval of the 0.5-mg dose. The FDA is not required to follow advisory committee recommendations when deciding whether or not to approve a drug, but usually does. The agency is expected to make its decision on Aug. 10. Lucentis already is approved for treating wet age-related macular degeneration.
DME is an eye condition in people with diabetes that causes swelling of the retina and blurred vision, and is a major cause of vision loss and blindness in diabetics, affecting more than 560,000 people in the United States.
"The committee's recommendation is an important step toward the goal of helping to redefine the standard of care for Americans with diabetic macular edema," Genentech chief medical officer and head of global product development Hal Barron said. "There has not been a major development in the treatment of DME for more than 25 years, and we look forward to the FDA's decision."