Eylea earns breakthrough therapy designation from FDA

The U.S. Food and Drug Administration has granted breakthrough therapy designation to Eylea for the treatment of diabetic retinopathy in patients with diabetic macular edema, according to a press release from Regeneron Pharmaceuticals.

The designation is based on results of the phase 3 VIVID-DME and VISTA-DME clincial trials, which showed that Eylea (aflibercept) yielded a significant improvement on disease severity scores in patients with diabetic macular edema, according to the release.

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

In the VIVID-DME trial, 29% of patients in a monthly treatment group and 33% of patients in a bimonthly treatment group who received five initial monthly injections had a two-step or better improvement on the diabetic retinopathy severity scale (DRSS), marking a significant difference from the 8% of patients in a laser control group who had a similar improvement, according to the release.

In the VISTA-DME trial, 40% of patients treated monthly and bimonthly with aflibercept had a two-step or better improvement on the DRSS; 17% of patients in a laser control group had a similar outcome, according to the news release.

Aflibercept is approved in the U.S., European Union and other countries for the treatment of wet age-related macular degeneration, macular edema following central retinal vein occlusion and DME.

The drug is currently undergoing regulatory review in the U.S. and E.U. for macular edema following branch retinal vein occlusion.