Regeneron announces FDA approval of EYLEA (aflibercept) Injection for diabetic retinopathy

Diabetic retinopathy in patients with DME is the fourth approved indication for EYLEA in the U.S.

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA® (aflibercept) Injection for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME). In 2014, the FDA granted EYLEA Breakthrough Therapy designation and Priority Review for the treatment of diabetic retinopathy in patients with DME.

"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."

The recommended dosage of EYLEA in patients with diabetic retinopathy in DME is 2 milligrams (mg) every two months (8 weeks) after five initial monthly injections. Although EYLEA may be dosed as frequently as 2 mg every 4 weeks, additional efficacy was not demonstrated when EYLEA was dosed every 4 weeks compared to every 8 weeks.

EYLEA is available as a single, 2 milligram (mg) strength intravitreal injection for all approved indications. EYLEA was previously approved in the U.S. for the treatment of wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and diabetic macular edema (DME).