Genentech Files Lucentis sBLA For Diabetic Retinopathy With FDA

Roche member group Genentech announced that it has filed a supplemental Biologics License Application (sBLA) for Lucentis for the treatment of diabetic retinopathy with the U.S. Food and Drug Administration (FDA).

Lucentis (ranibizumab injection) is a recombinant humanized monoclonal antibody fragment that is especially designed as a VEGF inhibitor in the eye. VEGF is a protein implicated in the formation of new blood vessels as well as their hyperpermeability, which leads to problems within the eye. Lucentis first received approval from the FDA in August 2012 for the treatment of diabetic macular edema and was the first in the U.S. for the indication. The drug has received regulatory approval for the treatment of DME-related visual impairment in over 75 countries.

Sandra Horning, CMO and head of Global Product Development at Genentech, said, “As the number of people impacted by diabetes continues to rise, so too will the number of people affected by diabetic eye disease.”

The company said its submission was supported by the results from the Phase III RISE and RIDE clinical trials, which showed significant efficacy and the safety of Lucentis. “We are committed to helping more people with diabetes prevent vision loss and look forward to continuing our discussions with the FDA about these data,” Dr. Horning said.

Diabetic retinopathy is the leading eye disease in diabetic patients, affecting almost 7.7 million patients in the U.S. If left untreated, diabetic retinopathy can eventually lead to blindness. Diabetic retinopathy has become the most common cause of new cases of blindness in working-age patients in the U.S., where more than 29 million are estimated to have diabetes. There are currently no approved ocular medications for the disease.

Lucentis has been compared to and contrasted with Avastin, which is a chemically similar but more expensive treatment for vision loss related to diabetic retinopathy. However, Avastin’s safety and efficacy compared to Lucentis has yet to be proven.

Both Lucentis and Avastin are manufactured by Genentech.