FDA expands Regeneron's Eylea approval

Aug. 13, 2019

Regeneron announced that the U.S. Food and Drug Administration has approved the a new Eylea (aflibercept) injection prefilled syringe. The 2 mg, single-dose, sterilized prefilled syringe will provide physicians with a new way to administer Eylea that will require less preparation compared to vials. Market supply of the prefilled syringe is expected to be available to physicians and patients this year.

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

In the United States, the drug is indicated to treat neovascular (wet) age-related macular degeneration (Wet AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME) and diabetic retinopathy (DR).

Read the press release