FDA Grants Priority Review for Genentech’s Lucentis in Diabetic Retinopathy

Genentech has announced that FDA has accepted to file the company's supplemental Biologics License Application (sBLA) and granted Priority Review of Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy, an eye disease that impacts nearly 7.7 million Americans. The FDA-confirmed action date is 6 February 2015.

The sBLA was submitted 7 August 2014 to address the unmet need for approved ocular medications for the treatment of diabetic retinopathy. If approved by FDA, Lucentis could be the first eye medicine available for diabetic retinopathy patients.

“Diabetes has emerged as a global epidemic, with 29 million people in the US with diabetes at risk of diabetic eye disease,” said Sandra Horning, MD, Chief Medical Officer and head of Global Product Development. “We are committed to the treatment of serious eye diseases for patients with diabetes and pleased FDA is moving forward in its consideration of Lucentis for diabetic retinopathy.”