FDA approves Eylea (aflibercept) for Diabetic Retinopathy in patients with Diabetic Macular Oedema-Regeneron Pharma

The FDA has approved Eylea (aflibercept) Injection, from Regeneron Pharma, for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME). In 2014, the FDA granted Eylea Breakthrough Therapy designation and Priority Review for the treatment of diabetic retinopathy in patients with DME.

The approval of Eylea for the treatment of diabetic retinopathy in DME was based on two year data from the Phase III VISTA-DME and VIVID-DME studies of 862 patients, which compared Eylea 2 mg monthly, Eylea 2 mg every two months (after five initial monthly injections), or macular laser photocoagulation (at baseline and then as needed). In these studies, on the primary endpoint of mean change in Best Corrected Visual Acuity (BCVA) at one year, patients treated with Eylea monthly or every two months showed statistically significant improvements compared to the control group. Patients in both Eylea 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 had a similar overall incidence of adverse events (AEs), ocular serious AEs, and non-ocular serious AEs across treatment groups and the control group.

Comment: Lucentis is first US-approved treatment for diabetic retinopathy in patients with diabetic macular edema (DME). But in the US Eylea has managed to steal market share because of a lower per-dose price and a shorter dosing schedule. In Europe, which is even more price-sensitive, selling Eylea at a discount to Lucentis may tip the scales in Bayer's favour. The market is large: Of the 29 million U.S. adults living with diabetes, 7.7 million have diabetic retinopathy, Regeneron said. About 1.5 million have a DME diagnosis, and another 1 million or so have DME.