Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Vabysmo® (faricimab-svoa) 6.0 mg single-dose prefilled syringe (PFS) for treating wet age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). These conditions collectively affect nearly three million individuals in the U.S. The Vabysmo PFS will be available to U.S. retina specialists and patients in the coming months.
“We are pleased that the U.S. FDA has approved the Vabysmo PFS for people living with wet AMD, DME, and RVO, which are leading causes of vision loss,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “While many retina specialists are already using Vabysmo as a first-line treatment, this new offering should make it even simpler to administer, thereby enhancing the treatment experience for both physicians and patients.”
Vabysmo PFS delivers the same medication as the currently available vials in a ready-to-use format. Vabysmo will also continue to be available in a 6.0 mg vial.
Vabysmo is the first bispecific antibody approved for ocular use, demonstrating rapid vision improvement and reduction in retinal swelling in wet AMD, DME, and RVO. Reduction in retinal swelling is crucial as fluid buildup in the eye can lead to distorted and blurred vision.
To date, Vabysmo has received approval in over 95 countries for wet AMD and DME and in several countries, including the U.S. and Japan, for RVO. Regulatory reviews are ongoing in other regions. Globally, more than four million doses of Vabysmo have been distributed since its initial U.S. approval in 2022.
Genentech remains dedicated to ensuring patients have access to prescribed medications, offering comprehensive services including support for access and reimbursement.
About Vabysmo® (faricimab-svoa)
Vabysmo is the first bispecific antibody approved for ocular use, targeting and inhibiting two pathways associated with various sight-threatening retinal conditions by blocking angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). These pathways are believed to contribute to vision loss by destabilizing blood vessels and promoting inflammation. By stabilizing blood vessels through Ang-2 and VEGF-A inhibition, Vabysmo is designed to preserve vision.
Vabysmo U.S. Indications
Vabysmo (faricimab-svoa) is a prescription medication administered via eye injection for treating adults with neovascular (wet) age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO).
