FDA approves Genentech’s Lucentis for diabetic retinopathy

First and only medicine FDA-approved to treat all forms of diabetic retinopathy.

The FDA granted Lucentis Priority Review for the treatment of diabetic retinopathy without DME based on an analysis of the Diabetic Retinopathy Clinical Research Network’s (DRCR.net) Protocol S study. This NIH-funded study compared Lucentis treatment to panretinal laser treatment in diabetic retinopathy patients both with and without DME. In the analysis that supported this approval, patients with and without DME in the Lucentis group experienced improvements in the severity of their retinopathy. Adverse events were consistent with those seen in previous studies.

“Diabetic retinopathy is the leading cause of vision loss among working-aged adults in the US between the ages of 20 and 74. We are very pleased that Lucentis is now FDA-approved to treat retinopathy in people with and without DME,” said Sandra Horning, chief medical officer and head of Global Product Development. “In multiple clinical studies, Lucentis demonstrated a significant improvement of patients’ diabetic retinopathy, and it is the first and only anti-VEGF therapy approved to treat all forms of diabetic retinopathy.”

Priority Review Designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease. The FDA previously granted Lucentis Breakthrough Therapy Designation for diabetic retinopathy in 2014 based on the pivotal RIDE and RISE Phase III clinical trials.