Roche’s Lucentis gets expanded approval from the FDA to treat diabetic retinopathy

Feb. 9, 2015 - PRLog -- The U.S. Food and Drug Administration has approved Roche’s Lucentis for the treatment of diabetic retinopathy (DR), in people with diabetic macular edema (DME). This is the fourth approved indication for Lucentis to treat serious eye diseases since 2006. Lucentis received  Breakthrough Therapy Designation from the FDA for this indication and Priority Review was granted 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.”

Patients afflicted with DR and DME are at risk for blindness as DR with DME is a common diabetic eye disease and a leading cause of blindness in American adults under 55.

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