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Vabysmo FDA Approval History

Last updated by Judith Stewart, BPharm on Oct 30, 2023.

FDA Approved: Yes (First approved January 28, 2022)
Brand name: Vabysmo
Generic name: faricimab-svoa
Dosage form: Intravitreal Injection
Company: Genentech, Inc.
Treatment for: Macular Degeneration, Diabetic Macular Edema, Macular Edema

Vabysmo (faricimab-svoa) is a vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2) inhibitor indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO).

Development timeline for Vabysmo

DateArticle
Oct 26, 2023Approval FDA Approves Genentech’s Vabysmo for the Treatment of Retinal Vein Occlusion (RVO)
Apr 25, 2023New Vabysmo Data Suggest Greater Retinal Drying Versus Aflibercept in Wet Age-Related Macular Degeneration and Diabetic Macular Edema
Jan 28, 2022Approval FDA Approves Vabysmo (faricimab-svoa) for the Treatment of Neovascular (Wet) Age-Related Macular Degeneration and Diabetic Macular Edema
Jan 24, 2022The Lancet Publishes Studies Showing Genentech’s Faricimab Improved and Maintained Vision in Two Leading Causes of Vision Loss, Extending Time Between Treatments up to Four Months
Jul 28, 2021FDA Accepts Application for Genentech’s Faricimab for the Treatment of Wet Age-Related Macular Degeneration (AMD) and Diabetic Macular Edema (DME)
Feb 11, 2021New Phase III Data Show Genentech’s Faricimab Is the First Investigational Injectable Eye Medicine to Extend Time Between Treatments up to Four Months in Two Leading Causes of Vision Loss, Potentially Reducing Treatment Burden for Patients
Jan 24, 2021Genentech’s Faricimab Meets Primary Endpoint in Two Global Phase III Studies and Shows Potential to Extend Time Between Treatments up to 16 Weeks for People With Neovascular Age-Related Macular Degeneration
Dec 20, 2020Genentech’s Faricimab Meets Primary Endpoint and Shows Strong Durability Across Two Global Phase III Studies for Diabetic Macular Edema, a Leading Cause of Blindness
Oct 27, 2018New STAIRWAY Study Data Shows Potential for Extended Durability With Faricimab in Wet Age-Related Macular Degeneration (AMD)

Further information

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