Regeneron Pharmaceuticals (NSDQ:REGN) said today that the FDA plans to review the supplemental biologics license application for Regeneron’s Eylea aflibercept injection for the treatment of diabetic retinopathy.
The U.S. agency plans to make a decision about the blockbuster drug by May 13, 2019.
Regeneron’s Eylea is dosed using a two-milligram intravitreal injection and is already approved to treat wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and DR in patients with DME.
In March, Regeneron announced results from a Phase III trial evaluating Eylea in patients with non-proliferative diabetic retinopathy. The study met its primary endpoint after 24 weeks – 58% of patients treated with Eylea had a two-step or greater improvement from baseline on the diabetic retinopathy severity scale compared to just 6% of patients receiving a sham injection.
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