FDA Grants Approval to Lucentis for Treatment of Diabetic Retinopathy

The FDA granted approval to ranibizumab injection (Lucentis) for the monthly treatment of all forms ofdiabetic retinopathy.

Ranibizumab injection is the first and only medication to be approved to treat all forms of diabetic retinopathy in patients who have been diagnosed with or without diabetic macular edema (DME).

The approval was based on an analysis of the Diabetic Retinopathy Clinical Research Network’s Protocol S study.

The randomized, active-controlled study comparing ranibizumab injection to panretinal or scatter photocoagulation (PRP) in 305 patients with proliferative diabetic retinopathy, including individuals with or without DME.

Study participants in the ranibizumab injection arm received a baseline 0.5 mg intravitreal injection followed by 3 monthly intravitreal injections. After which, treatment was guided by prespecified retreatment criteria, according to the press release.

The results of the analysis that supported the approval showed that 37.8% of patients in the ranibizumab injection arm without baseline DME had a 2-step or better improvement in their diabetic retinopathy, and 28.4% had a 3-step or better improvement at 2 years.

In the ranibizumab injection study portion consisting of patients with baseline DME, the results showed that 58.5% had a 2-step or better improvement in their diabetic retinopathy, and 31.7% had a 3-step or better improvement at 2 years.

Adverse effects observed were similar to those seen in other trials of ranibizumab injection, according to the release.

“Diabetic retinopathy is the leading cause of vision loss among working-aged adults in the US between the ages of 20 and 74,” Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, said in a press release. “We are very pleased that Lucentis is now FDA-approved to treat retinopathy in people with and without DME. 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.”