FDA approves ranibizumab for all forms of diabetic retinopathy

Ranibizumab has become the first FDA-approved medicine for treatment of diabetic retinopathy (DR), either with or without diabetic macular edema (DME).

The FDA had granted ranibizumab priority review based on an analysis of the Diabetic Retinopathy Clinical Research Network (DRCR.net) Protocol S study, which compared ranibizumab to panretinal laser treatment for DR patients with and without DME.

The RIDE and RISE clinical trials previously supported the 2015 FDA approval of ranibizumab for DR with DME.

“In multiple clinical studies, Lucentis demonstrated a significant improvement of patients’ diabetic retinopathy,” said Sandra Horning, MD, chief medical officer and head of global product development for Genentech.

The approval adds to the growing list of indications for ranibizumab, which includes the treatment of wet age-related macular degeneration (AMD), macular edema after retinal vein occlusion (RVO), myopic choroidal neovascularization (CNV) and DME.