EU approves Eylea for DME

On the heels of last month’s U.S. FDA approval, the European Commission has approved Eylea (aflibercept) for diabetic macular edema (DME). The company plans for an immediate launch, with Germany being the first in line.

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.

Bayer and Regeneron Pharmaceuticals are collaborating on the global development of Eylea. Regeneron maintains exclusive rights in the United States. Bayer has exclusive marketing rights outside the United States, where the companies share Eylea sales profits equally, except for Japan where Regeneron receives a percentage of net sales.