On May 13, 2019, the U.S. Food and Drug Administration (FDA) expanded the approved use of eye drug Eylea (aflibercept) to include treatment of all stages of diabetic retinopathy. More than 5.3 million adults in the United States are estimated to have diabetic retinopathy, which occurs when diabetes damages tiny blood vessels in the eye’s retina (the light-sensitive tissue at the back of the eye).
Eylea, which is also approved to treat wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy in people who have diabetic macular edema is administered via injection into the eye — monthly for the first five months and then once every other month — by a health-care professional.
The approval was based on the results of the phase 3 PANORAMA trial, which evaluated the effect of Eylea on moderately severe to severe non-proliferative diabetic retinopathy compared to a sham (inactive) injection in 402 participants.
For more information about Eylea, see the press release on the Regeneron website.