FDA Approves Genentech’s Lucentis® (Ranibizumab Injection) for Treatment of Diabetic Retinopathy in People with Diabetic Macular Edema

South San Francisco, Calif. -- February 6, 2015 - Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) approved Lucentis® (ranibizumab injection) for the treatment of diabetic retinopathy (DR) in people with diabetic macular edema (DME). DME impacts nearly 750,000 Americans, about 10 percent of people with DR.

The FDA granted Lucentis Breakthrough Therapy Designation and Priority Review for this indication based on results from the RISE and RIDE Phase III clinical trials.

"While there are various options for treating diabetic macular edema, before today none were approved showing improvement in retinopathy," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "With today's approval, people with diabetic macular edema now have a FDA-approved medicine that showed meaningful improvements in retinal damage from diabetes, in addition to the established improvement in vision."... Genentech's Press Release -