Eylea FDA Approval History
FDA Approved: Yes (First approved November 18, 2011)
Brand name: Eylea
Generic name: aflibercept
Dosage form: Injection
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: Macular Degeneration, Macular Edema, Diabetic Retinopathy, Diabetic Macular Edema, Retinopathy of Prematurity
Eylea (aflibercept) is a VEGF inhibitor indicated for the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and retinopathy of prematurity.
Development timeline for Eylea
|Feb 8, 2023||Approval Eylea (aflibercept) Injection Approved as the First Pharmacologic Treatment for Preterm Infants with Retinopathy of Prematurity (ROP) by the FDA|
|Aug 13, 2019||Approval FDA Approves Eylea (aflibercept) Injection Prefilled Syringe |
|May 13, 2019||Approval FDA Approves Eylea (aflibercept) Injection for Diabetic Retinopathy|
|Aug 17, 2018||Approval FDA Approves New Eylea (aflibercept) Injection Dosing Schedule in Wet Age-Related Macular Degeneration|
|Mar 25, 2015||Approval FDA Approves Eylea (aflibercept) for Diabetic Retinopathy in Patients with Diabetic Macular Edema|
|Oct 6, 2014||Approval Eylea (aflibercept) Injection Receives FDA Approval for Macular Edema Following Retinal Vein Occlusion (RVO)|
|Jul 29, 2014||Approval Eylea (aflibercept) Injection Receives FDA Approval for the Treatment of Diabetic Macular Edema|
|Nov 18, 2011||Approval FDA Approves Eylea for Wet Age-Related Macular Degeneration|
|Aug 17, 2011||Regeneron Announces Review of Biologics License Application for Eylea (aflibercept injection) Extended by Three Months by FDA|
|Jun 17, 2011||Regeneron Announces Eylea (aflibercept ophthalmic solution) Receives Unanimous Recommendation for Approval for Treatment of Wet AMD from FDA Advisory Committee|
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