FDA approves Lucentis for all forms of diabetic retinopathy
The FDA has approved Lucentis for monthly treatment of all forms of diabetic retinopathy, according to a press release from Genentech/Roche.
The 0.3 mg injection of ranibizumab is the first FDA drug approved to treat diabetic retinopathy “with or without diabetic macular edema,” according to the release.
Lucentis for diabetic retinopathy without diabetic macular edema was granted priority review based on the Diabetic Retinopathy Clinical Research Network Protocol S study. RIDE and RISE clinical trials had previously supported the 2015 FDA approval of ranibizumab for diabetic retinopathy with diabetic macular edema.
“In multiple clinical studies, Lucentis demonstrated a significant improvement of patients’ diabetic retinopathy,” Sandra Horning, MD, chief medical officer and head of global product development for Genentech, said in the release.
Lucentis is also approved by the FDA for the treatment of wet age-related macular degeneration, macular edema after retinal vein occlusion, myopic choroidal neovascularization and diabetic macular edema.
It is approved for wet AMD, DME and macula edema in more than 100 countries as well.