Monday, July 15, 2024

Vision Breakthrough: FDA Approves Genentech’s Vabysmo Prefilled Syringe (PFS) for Three Leading Causes of Vision Loss

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Vision treatment has advanced with Genentech, a member of the Roche Group, announcing that the U.S. Food and Drug Administration (FDA) has approved the Vabysmo® (faricimab-svoa) 6.0 mg single-dose prefilled syringe (PFS) for wet, or neovascular, age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). These three conditions collectively affect nearly three million people in the United States. The Vabysmo PFS is expected to be available to U.S. retina specialists and their patients in the coming months.

Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development, expressed satisfaction with the FDA’s approval, stating, “We are pleased that the U.S. FDA has approved the Vabysmo PFS for people living with wet AMD, DME, and RVO, which are some of the leading causes of vision loss.” Dr. Garraway highlighted that many retina specialists are already using Vabysmo as a first-line treatment and that the new prefilled syringe format will simplify administration, thereby enhancing the treatment experience for both physicians and patients.

Vision Improvement: Vabysmo PFS Offers Ready-to-Use Format and Effective Retinal Drying

The Vabysmo PFS delivers the same medicine as the currently available Vabysmo vials but in an alternative, ready-to-use format. The medicine will continue to be available in a 6.0 mg vial. Vabysmo is the first and only bispecific antibody approved for the eye and has shown rapid and robust improvements in vision and retinal drying in patients with wet AMD, DME, and RVO. Retinal drying is crucial as swelling from excess fluid in the back of the eye is associated with distorted and blurred vision.

Vabysmo has been approved in more than 95 countries for the treatment of wet AMD and DME, and in several countries, including the U.S. and Japan, for RVO. Reviews by other health authorities worldwide are ongoing. Since its initial U.S. approval in 2022, more than four million doses of Vabysmo have been distributed globally.


Vision Access: Genentech Ensures Availability and Support for Vabysmo Patients

Genentech is dedicated to ensuring patients can access the medications they are prescribed. The company offers comprehensive services to minimize barriers to access and reimbursement for those prescribed Vabysmo. Patients seeking more information can call 833-EYE-GENE, and those who qualify can access patient assistance programs through Genentech Access Solutions.

Vabysmo is the first bispecific antibody approved for the eye. It targets and inhibits two signaling pathways linked to several vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). While ongoing research aims to better understand the role of the Ang-2 pathway in retinal disease, Ang-2 and VEGF-A are believed to contribute to vision loss by destabilizing blood vessels, leading to the formation of new leaky blood vessels and increased inflammation.

By blocking the pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilize blood vessels. Vabysmo (faricimab-svoa) is a prescription medicine administered by injection into the eye. It is used to treat adults with neovascular (wet) age‑related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO).


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Resource: Business Wire, July 05, 2024

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