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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, 2023Approval Eylea (aflibercept) Injection Approved as the First Pharmacologic Treatment for Preterm Infants with Retinopathy of Prematurity (ROP) by the FDA
Aug 13, 2019Approval FDA Approves Eylea (aflibercept) Injection Prefilled Syringe
May 13, 2019Approval  FDA Approves Eylea (aflibercept) Injection for Diabetic Retinopathy
Aug 17, 2018Approval FDA Approves New Eylea (aflibercept) Injection Dosing Schedule in Wet Age-Related Macular Degeneration
Mar 25, 2015Approval FDA Approves Eylea (aflibercept) for Diabetic Retinopathy in Patients with Diabetic Macular Edema
Oct  6, 2014Approval Eylea (aflibercept) Injection Receives FDA Approval for Macular Edema Following Retinal Vein Occlusion (RVO)
Jul 29, 2014Approval Eylea (aflibercept) Injection Receives FDA Approval for the Treatment of Diabetic Macular Edema
Nov 18, 2011Approval FDA Approves Eylea for Wet Age-Related Macular Degeneration
Aug 17, 2011Regeneron Announces Review of Biologics License Application for Eylea (aflibercept injection) Extended by Three Months by FDA
Jun 17, 2011Regeneron Announces Eylea (aflibercept ophthalmic solution) Receives Unanimous Recommendation for Approval for Treatment of Wet AMD from FDA Advisory Committee

Further information

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