FDA approves aflibercept for DME treatment

Tarrytown, NY-The FDA has approved Regeneron’s aflibercept (Eylea) for the treatment of diabetic macular edema (DME).

"(DME) is a leading cause of vision loss among working-age adults in the United States, and we are pleased to be able to offer a new treatment option to these patients," said George D. Yancopoulos, MD, PhD, chief scientific officer of Regeneron and president of Regeneron Laboratories. "Our clinical studies have demonstrated that treatment with (aflibercept) can help improve and maintain vision with every 8 week dosing after 5 initial monthly doses.

“(This drug) is the first VEGF inhibitor approved for dosing on a less-than-monthly basis for the treatment of DME,” he added.

The approval of aflibercept in DME was based on the 1-year data from the phase III VISTA-DME and VIVID-DME studies of 862 patients, which compared:

·      Two mg of the drug given monthly

·      Two mg of the drug given every 2 months (after 5 initial monthly injections)

·       Macular laser photocoagulation (at baseline and then as needed)

In the DME studies, after 1 year, the mean changes in best-corrected visual acuity-as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart for the monthly and every 2 month aflibercept groups-were significantly improved compared with the control group, and were similar to each other.

Across both trials, patients in both aflibercept-dosing groups gained, on average, the ability to read about two additional lines on an eye chart compared with almost no change in the control group.

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