FDA approves Eylea for treatment of Diabetic Macular Edema - Regeneron

Regeneron Pharmaceuticals, Inc. has announced that the FDA has approved Eylea (aflibercept) Injection for the treatment of Diabetic Macular Edema (DME). The recommended dosage of Eylea in patients with DME is 2 milligrams (mg) every two months (8 weeks) after five initial monthly injections. Although Eylea may be dosed as frequently as 2 mg every 4 weeks, additional efficacy was not demonstrated when Eylea was dosed every 4 weeks compared to every 8 weeks.

The approval of Eylea in DME was based on the one-year data from the Phase III VISTA-DME and VIVID-DME studies of 862 patients, which compared EYLEA 2 mg given monthly, Eylea 2 mg given every two months (after five initial monthly injections), or macular laser photocoagulation (at baseline and then as needed). In the DME studies, after one year, the mean changes in Best Corrected Visual Acuity (BCVA), as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart for the monthly and every two month Eylea groups, were statistically significantly improved compared to the control group and were similar to each other. Across both trials, patients in both Eylea dosing groups gained, on average, the ability to read approximately two additional lines on an eye chart compared with almost no change in the control group.

Eylea is approved with an eight-weekly dosing schedule (after five initial monthly shots), which means Eylea becomes the first VEGF inhibitor on the market for Diabetic Macular Edema administered on a less than monthly basis, offering extra convenience to patients.