FDA approves Eylea to treat diabetic retinopathy

Regeneron Pharmaceuticals, Inc. announced that the FDA has approved Eylea (aflibercept) Injection to treat all stages of diabetic retinopathy (DR), and thereby reduce the risk of blindness. Eylea is the only vascular endothelial growth factor (VEGF) inhibitor approved with two dosing options for DR, allowing doctors to customize treatment to their patients' needs. In Diabetic Retinopathy, Eylea may be dosed every eight weeks following five initial monthly injections, or every four weeks.

The FDA approval of Eylea as a treatment for Diabetic Retinopathy was based on six-month and one-year results from PANORAMA, a randomized, multi-center, controlled Phase III trial that enrolled 402 patients and was designed to investigate EYLEA for the improvement of moderately severe to severe NPDR without diabetic macular edema (DME), compared to sham injection. PANORAMA is the first prospective trial to study whether an anti-VEGF can also help prevent worsening disease in patients with NPDR without DME.