▎WuXiEdited by Kant Content Team

Today, Roche announced that the U.S. FDA has approved its bispecific antibody Vabysmo (faricimab) 6.0 mg single-dose pre-filled syringe (PFS) for the treatment of neovascular or wet age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema caused by retinal vein occlusion (RVO).These three diseases combined affect nearly 80 million people worldwide.According to the press release, Vabysmo PFS is the first prefilled bispecific antibody injector approved by the FDA for the treatment of retinal diseases that may cause blindness.

Vabysmo is a bispecific antibody that simultaneously targets and blocks two key pathogenic pathways—angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A)—both of which can destabilize blood vessels., causing blood vessels to leak, increasing inflammation, and thereby driving many retinal diseases that can lead to vision loss. Targeting both pathways simultaneously can have a complementary effect, so Vabysmo is expected to stabilize blood vessels and improve patients' vision. The expression of Ang-2 increases in patients with retinal vein occlusion, and the increase in Ang-2 expression is considered to be associated with the progression of this disease. This therapy was approved in January 2022.FDA ApprovalUsed to treat wet or neovascular age-related macular degeneration and diabetic macular edema, and in October last yearApprovedUsed to treatRetinal Vein Occlusion.

According to the press release,Vabysmo is the first bispecific antibody approved for ophthalmic use., showing rapid and significant improvement in vision and retinal drying effects in nAMD, DME, and RVO. Retinal drying is an important clinical indicator because swelling caused by excess fluid in the back of the eye can lead to distorted and blurred vision.VabysmoThe design of PFS simplifies the drug administration process, providing healthcare professionals with a ready-to-use option.

Vabysmo PFS provides the same medication as the currently available Vabysmo vial but in an alternative, ready-to-use format. Vabysmo will continue to be available in a 6.0 mg vial format.

References:

[1] FDA approves Roche’s Vabysmo prefilled syringe (PFS) for three leading causes of vision loss. Retrieved July 5, 2024 from https://www.globenewswire.com/news-release/2024/07/05/2908869/0/en/FDA-approves-Roche-s-Vabysmo-prefilled-syringe-PFS-for-three-leading-causes-of-vision-loss.html

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