Regeneron's Eylea scores Breakthrough label

Regeneron's Eylea (aflibercept) nabbed an FDA Breakthrough Therapy designation for diabetic retinopathy for patients with diabetic macular edema. The Tarrytown, NY, company said in a statement Tuesday that Phase-III trials showing “statistically significant improvement in a pre-specified measure of diabetic retinopathy in patients with DME after two years of treatment” helped it score the Breakthrough label.

The injection is currently approved for wet age-related macular degeneration, macular edema following central retinal vein occlusion and diabetic macular edema.


Next Article in Channel