Regeneron Pharmaceuticals, Inc. has announced FDA approval of Eylea (aflibercept) injection to treat all stages of diabetic retinopathy.
Eylea is already approved for treatment of three conditions: neovascular (wet) age-related macular degeneration, macular edema resulting from retinal vein occlusion, and diabetic macular edema.
This additional use of Eylea for diabetic retinopathy was approved based upon encouraging results from Regeneron’s phase III PANORAMA study. After one year, the study showed that 80% and 65% of patients receiving Eylea every 8 weeks and 16 weeks respectively, achieved significant improvement compared to 15% of patients who received sham injections.