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Vabysmo FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 31, 2022.

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

Vabysmo (faricimab-svoa) is a bispecific antibody targeting the vascular endothelial growth factor (VEGF) and angiopoietin 2 (Ang-2) pathways for the treatment of neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME).

  • Wet age-related macular degeneration is caused by growth of abnormal blood vessels into the macula. Diabetic macular edema occurs when damaged blood vessels in the retina leak into and cause swelling in the macula.
  • Angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) both contribute to vision loss by destabilizing blood vessels, causing inflammation and the formation of new leaky blood vessels in AMD and DME. Vabysmo works to stabilize blood vessels by blocking pathways involving Ang-2 and VEGF-A.
  • Vabysmo is administered by intravitreal injection every 4 weeks for the first four doses, then at a regimen determined after clinical evaluation.
  • Common adverse reactions include conjunctival hemorrhage.

Development timeline for Vabysmo

DateArticle
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)

See also

Vabysmo (faricimab-svoa) Consumer information

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer