Genentcch/Roche files Lucentis at FDA for treatment of Diabetic Retinopathy.

Genentech/Roche has submitted a supplemental Biologics License Application (sBLA) for Lucentis (ranibizumab injection) to the FDA for the treatment of Diabetic Retinopathy. The submission is based on results of the RISE and RIDE Phase III clinical trials demonstrating the safety and efficacy of Lucentis for this serious eye disease. There are currently no ocular medications approved for the treatment of Diabetic Retinopathy.

Diabetic Retinopathy is the most common diabetic eye disease, impacting nearly 7.7 million Americans. The longer a person has diabetes, especially if it is poorly controlled, the higher the risk for developing Diabetic Retinopathy. It eventually affects nearly all diabetes patients and if left untreated, can lead to blindness. This eye disease is the leading cause of new cases of blindness in working-age Americans.