FDA approves aflibercept for diabetic retinopathy

The U.S. FDA has approved aflibercept (Eylea) at less than monthly dosing to treat diabetic retinopathy in diabetic macular edema patients, according to Regeneron Pharmaceuticals.

The anti-VEGF is already approved in the United States for the treatment of wet AMD, macular edema following retinal vein occlusion and diabetic macular edema.

Approval is based on outcomes from the phase 3 VISTA-DME and VIVID-DME studies which showed that BCVA improved significantly in patients injected with aflibercept 2 mg monthly or every two months(following a loading dose of 5  monthly injections), compared with patients who underwent macular laser photocoagulation at baseline and then as needed.

Data demonstrated that aflibercept was no more effective when dosed every 4 weeks compared with every 8 weeks.