FDA approves Eylea for DME

Regeneron Pharmaceuticals, Inc. announced that the U.S. FDA has approved Eylea (aflibercept) for diabetic macular edema (DME).

Already approved in the United States and the European Union for wet AMD and macular edema following central retinal vein occlusion, Eylea is under consideration for DME in Japan, Asia Pacific and Latin America. The anti-VEGF is also under consideration for macular edema following branch retinal vein occlusion in the United States and European Union

Eylea acts as a soluble decoy receptor that binds VEGF-A and placental growth factor, thereby inhibiting the binding and activation of their cognate VEGF receptors. The recommended dosage for DME is 2 mg every two months after five initial monthly injections.

The phase 3 VIVID-DME and VISTA-DME double-masked studies showed monthly dosing and dosing every two months resulted in significantly greater improvement in BCVA from baseline compared to laser photocoagulation at 52 weeks. Eylea was generally well tolerated with a similar overall incidence of adverse events. The two studies are expected to continue as planned up to 148 weeks.