Regeneron announced that the Food and Drug Administration (FDA) has granted Eylea (afilbercept) Injection Breakthrough Therapy designation for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME).
The designation is based on positive results from two Phase 3 trials (VIVID-DME and VISTA-DME) in which Eylea demonstrated statistically significant improvement in a pre-specified measure of diabetic retinopathy in patients with DME after two years of treatment.
Eylea is a vascular endothelial growth factor (VEGF) inhibitor designed to block the growth of new blood vessels and decreases vascular permeability in the eye by blocking VEGF-A and placental growth factor (PlGF), two growth factors involved in angiogenesis. Eylea helps prevent VEGF-A and PlGF from interacting with their natural VEGF receptors as shown in preclinical studies.
Eylea is already approved for the treatment of neovascular (wet) age-related macular degeneration (AMD) and macular edema following central retinal vein occlusion (CRVO).
For more information call (855) 734-3648 or visit Regeneron.com.