FDA Approves Lucentis for Diabetic Retinopathy

Only treatment for patients with or without DME

The FDA has given the nod to ranibizumab injection (Lucentis, Genentech) for the monthly treatment of all forms of diabetic retinopathy. With this approval, ranibizumab becomes the only FDA-approved medication to treat diabetic retinopathy in patients who have been diagnosed either with or without diabetic macular edema (DME), a complication of diabetic retinopathy that causes swelling in the back of the eye.

In February 2015, ranibizumab received FDA approval for the treatment of diabetic retinopathy in patients with DME, based on data from the pivotal phase 3 RIDE and RISE clinical trials.

The agency had granted ranibizumab priority review status for the treatment of patients with 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 ranibizumab with panretinal laser treatment, also known as scatter photocoagulation, in 305 patients with proliferative diabetic retinopathy, including those with or without DME. In the ranibizumab group (n = 148), patients received a baseline 0.5-mg intravitreal injection followed by three monthly intravitreal injections, after which treatment was guided by prespecified retreatment criteria.

In the analysis that supported the new approval, 37.8% (56/148) of patients in the ranibizumab group without baseline DME had a two-step or better improvement in their diabetic retinopathy and 28.4% (42/148) had a three-step or better improvement at two years, according to the Early Treatment Diabetic Retinopathy Study–Diabetic Retinopathy Severity Scale (ETDRS-DRSS). In ranibizumab-treated patients with baseline DME, 58.5% (24/41) had a two-step or better improvement in their diabetic retinopathy and 31.7% (13/41) had a three-step or better improvement at two years.

Ranibizumab is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in angiogenesis and in hyperpermeability of the vessels. The treatment was previously approved for patients with DME; wet age-related macular degeneration; macular edema after retinal-vein occlusion; diabetic retinopathy; and myopic choroidal neovascularization.

Source: Genentech; April 17, 2017.