Regeneron Pharmaceuticals announced that the FDA has classified Eylea as a breakthrough therapy to treat diabetic retinopathy in patients who already have diabetic macular edema.This classification expedites the process for Eylea to be FDA approved.
Currently, Eylea has FDA approval for treatment of wet age-related macular degeneration, macular edema associated with central retinal vein occlusion and diabetic macular edema. Eylea works by preventing the growth of new blood vessels, lessening the ability of fluid to pass through blood vessels and blocking the body's growth factors.
Two phase 3 clinical trials of Eylea showed that patients receiving the injections showed a marked improvement after two years of treatment in lessening the severity of diabetic retinopathy in patients who suffered from diabetic macular edema. Presently, there are no FDA- approved medicines for diabetic retinopathy and Regeneron hopes that Eylea will be available to patients in the very near future.*