FDA Approves Lucentis for All Forms of Diabetic Retinopathy

Today, the FDA approved ranibizumab injection (Lucentis) 0.3-mg for the treatment of all forms of diabetic retinopathy.

Diabetic retinopathy is the most common cause of blindness and vision loss in patients with diabetes, affecting nearly 7.7 million individuals in the United States, according to a press release.

The latest approval makes ranibizumab injection the only drug indicated to treat patients with or without diabetic macular edema (DME), which causes swelling of the retina.

Ranibizumab injection is a vascular endothelial growth factor (VEGF) inhibitor that binds to and inhibits the protein VEGF-A, which is involved with the formation of novel blood vessels and the leaking of existing vessels. It was previously approved for wet age-related macular degeneration, macular edema after retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.

The FDA previously approved ranibizumab injection for the treatment of diabetic retinopathy in patients with DME in February 2015. The approval was supported by positive data from phase 3 clinical trials, according to Genentech.

The FDA granted the drug priority review in patients without DME based on findings from the Diabetic Retinopathy Clinical Research Network’s Protocol S study, funded by the National Institutes of Health. In this study, the authors analyzed the efficacy of ranibizumab injection compared with panretinal laser treatment in 305 patients with diabetic retinopathy with and without DME.

The authors discovered that patients with and without DME treated with ranibizumab injection were observed to have improvements in disease severity.

Approximately 37.8% of patients without DME treated with the drug had a 2-step or better improvement in diabetic retinopathy, while 28.4% had a 3-step or better improvement at 2 years, according to the study. Among patients with DME treated with ranibizumab injection, 58.5% had a 2-step or better improvement and 31.7% had a 3-step or better improvement at 2 years.

Genentech reported that adverse events were consistent with 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, MD, chief medical officer and head of Global Product Development at Genentech. “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.”