FDA Approves Regeneron’s Eylea for Eye Disease

August 20, 2019

FDA has approved Regeneron Pharmaceuticals’ Eylea (aflibercept), an anti-vascular endothelial growth factor inhibitor, to treat four retinal conditions.

Regeneron Pharmaceuticals announced on Aug. 13, 2019 that FDA approved Eylea (aflibercept) Injection prefilled syringe for treating four retinal conditions. The drug is expected to be available to physicians and patients this year.

In the United States, Eylea is indicated to treat neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

Eylea Injection is a vascular endothelial growth factor (VEGF) inhibitor designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor, two growth factors involved in angiogenesis.

"With eight pivotal Phase [III] trials and millions of injections used around the world, [Eylea] sets a high bar for visual acuity and safety across multiple retinal diseases, including wet age-related macular degeneration and diabetic eye diseases," said George D. Yancopoulos, MD, PhD, president and chief scientific officer of Regeneron, in a company press release. "This approval may help doctors more conveniently and efficiently deliver [Eylea] to appropriate patients."

The sterilized prefilled syringe offers the same medicine as the currently available Eylea in an easier to use and administer mode.

Source: Regeneron Pharmaceuticals