Prefilled Syringe Formulation of Eylea Gets FDA Approval

The Food and Drug Administration (FDA) has approved Eylea (aflibercept; Regeneron) injection in a prefilled syringe formulation. Prior to the approval, Eylea had only been available in 2mg single-dose vials. 

Eylea, a vascular endothelial growth factor (VEGF) inhibitor, was originally approved in November 2011 for the treatment of neovascular (wet) age-related macular degeneration. In addition, Eylea is also indicated for the treatment of macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

Compared with the vials, the new prefilled syringe reduces the number of preparation steps for clinicians administering Eylea. The 2mg/0.05mL, single-dose, sterilized prefilled syringe is expected to be available sometime this year; single-use vials will continue to be available in a 2mg/0.05mL dosage strength. Eylea is administered by intravitreal injection; each prefilled syringe or vial is for single eye use only. 

“With eight pivotal Phase 3 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. “This approval may help doctors more conveniently and efficiently deliver Eylea to appropriate patients.”

For more information visit eylea.us.