Diabetic Retinopathy Treatment Receives FDA Priority Review
The FDA has granted priority review to Roche's injectable ranibizumab (Lucentis) treatment for diabetic retinopathy.
The FDA has granted priority review to Roche’s injectable ranibizumab (Lucentis) treatment for diabetic retinopathy, the most common eye disease among patients with diabetes.
“Diabetes has emerged as a global epidemic, with 29 million people in the United States with diabetes at risk of diabetic eye disease,” said Sandra Horning, MD, chief medical officer and head of global product development at Roche, in a statement. “We are committed to the treatment of serious eye diseases for patients with diabetes and pleased the FDA is moving forward in its consideration of Lucentis for diabetic retinopathy.”
The FDA grants priority review designation to drugs that can potentially provide significant improvements in the safety or efficacy of treating, diagnosing, or preventing severe conditions. In an effort to address the unmet need for ocular medications for diabetic retinopathy, Roche submitted a supplemental biologics license application for Lucentis on August 7, 2014, which has a confirmed FDA action date of February 6, 2015.
The application for the drug was based on 2 identically designed phase 3 trials that examined 759 patients with baseline diabetic retinopathy severity scores ranging from 10 to 75 in their studied eye. In both studies, the benefits of Lucentis treatment were achieved at year 2 and maintained through year 3.
Lucentis is a vascular endothelial growth factor (VEGF) inhibitor that binds to and blocks the VEGF-A protein, which is believed to play a role in the leakiness of new blood vessels.
If the drug’s supplemental application receives FDA approval, Lucentis could become the first eye medication available for diabetic retinopathy patients. It is currently approved in the United States to treat patients with wet age-related macular degeneration, macular edema following retinal vein occlusion, and diabetic macular edema.