Roche’s Genentech unit said Thursday that a panel of federal medical advisers recommended approving its drug Lucentis for a new use in treating patients with a diabetes-related eye condition.
The 10 members of the Food and Drug Administration’s skin and eye drug panel unanimously voted to approve the drug to treat diabetic macular edema, a condition that causes swelling and blurred vision in patients with diabetes. About half a million people in the U.S. have the condition.
The FDA is not required to follow the group’s guidance, though it often does. The FDA is expected to issue its decision on the new indication by Aug. 10.
Lucentis is currently marketed for wet, age-related macular degeneration, the leading cause of blindness among the elderly in the U.S. The drug has been facing new competition in that space from Regeneron Pharmaceutical’s Eylea, which is cheaper and can be administered with fewer injections.
