Eylea wins FDA breakthrough therapy status

The FDA has granted Eylea (aflibercept) breakthrough therapy status for treating diabetic retinopathy in patients with diabetic macular edema (DME).

The designation, created by the FDA to expedite the development and review of drugs for serious or life-threatening conditions, is based on results in two phase 3 trials (VIVID-DME and VISTA-DME) in which Eylea demonstrated a statistically significant improvement on disease severity scores in patients with DME.

"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,” said George D. Yancopoulos, MD, PhD, chief scientific officer of Regeneron and president of Regeneron Laboratories. “We plan to submit a supplemental Biologics License Application (sBLA) in the U.S. for diabetic retinoapthy in patients with DME later this year."

In the VIVID-DME trial, 29% of evaluable patients in a monthly treatment group and 33% of evaluable patients in a bimonthly treatment group who received 5 initial monthly injections had a two-step or better improvement on the diabetic retinopathy severity scale (DRSS) compared to 8 percent of patients in the laser control group (P < 0.001). In the VISTA-DME, 40 percent of evaluable patients treated monthly and bimonthly with Eylea had a two-step or better improvement on the DRSS compared to 17 percent of patients in the laser control group (P < 0.0001).

Eylea is approved in the United States, European Union and other countries for the treatment of wet AMD, macular edema following central retinal vein occlusion, and DME. The drug is currently undergoing regulatory review in the United States and European Union for macular edema following branch retinal vein occlusion.