Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Eylea (aflibercept) Injection Breakthrough Therapy designation for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME). The designation is based on positive results in two Phase 3 trials (VIVID-DME and VISTA-DME), in which Eylea demonstrated a statistically significant improvement in a pre-specified measure of diabetic retinopathy in patients with DME after two years of treatment.

"Millions of people in the U.S. are living with diabetic eye diseases that can cause vision loss and even blindness," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "There are no FDA-approved medicines for diabetic retinopathy and we look forward to working closely with the FDA to potentially bring Eylea to these patients as soon as possible. We plan to submit a supplemental Biologics License Application (sBLA) in the U.S. for diabetic retinoapthy in patients with DME later this year."

For more details, go to: http://investor.regeneron.com/releases.cfm