The FDA has approved Genentech’s ranibizumab injection (Lucentis) for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME).
The FDA granted ranibizumab Breakthrough Therapy Designation and Priority Review for the indication based on results from the RISE and RIDE phase III clinical trials.
“While there are various options for treating DME, before today none were approved showing improvement in retinopathy,” said Sandra Horning, MD, chief medical officer and head of global product development for Genentech. “With today's approval, people with DME now have an FDA-approved medicine that showed meaningful improvements in retinal damage from diabetes, in addition to the established improvement in vision.”
According to the company, ranibizumab was the first medicine approved by the FDA for the treatment of DME in 2012, and has been an important option for patients with wet age-related macular degeneration since 2006 and macular edema following retinal vein occlusion since 2010.