NAPSR News: Regeneron’s EYLEA® receives expanded approval from the FDA

WASHINGTON - March 27, 2015 - PRLog -- The U.S. Food and Drug Administration (FDA) has officially greenlighted Regeneron’s EYLEA® (aflibercept) Injection to treat Diabetic Retinopathy in Patients with Diabetic Macular Edema (DME) which marks the fourth approved indication for the drug in the U.S. EYLEA is already approved to treat wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and diabetic macular edema (DME).

EYLEA® had already received Breakthrough Therapy designation and Priority Review from the FDA to treat diabetic retinopathy in patients with DME in 2014 based on preliminary clinical evidence. "Diabetic retinopathy coupled with DME is a serious complication of diabetes that can threaten the vision of many working-age adults," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "In addition to improving visual acuity in people with DME, EYLEA also improves these patients' retinal vessel damage, or retinopathy. EYLEA is the only treatment option for diabetic retinopathy in patients with DME that is approved for less than monthly dosing after an initial monthly dosing period."

Regeneron will see a significant boost in U.S sales based on the new approved indication. Last year sales of EYLEA® increased 48% to $2.8 billion compared to 2013.

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