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FDA Approves Roche’s New Prefilled Syringe for Vision Loss Treatment

Swiss pharma giant Roche has announced that the United States Food and Drug Administration (US FDA) has approved the its faricimab, the first bispecific antibody approved for use in the eye, targeting two key proteins involved in these conditions, namely, angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) and marketed as Vabysmo prefilled syringe (PFS) for treating three major causes of vision loss. This approval covers neovascular or 'wet' age-related macular degeneration (nAMD), diabetic macular edoema (DME), and macular edoema after retinal vein occlusion (RVO).

In a statement, Roche informed that the Vabysmo PFS is unique in that it is the first and only prefilled syringe containing an FDA-approved bispecific antibody developed for eye disorders that can cause blindness. This new format intends to make the treatment procedure easier for retinal doctors by providing a ready-to-use solution. US retina experts and patients will have access to Vabysmo PFS in the coming months.

Commenting on the development, Roche's Chief Medical Officer and Head of Global Product Development, Dr Levi Garraway, said, “We are pleased that the US FDA has approved the Vabysmo PFS for people living with neovascular age-related macular degeneration, diabetic macular edema and retinal vein occlusion, which are some of the leading causes of vision loss,” 

 “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,”  he added.

He further pointed out that the new syringe contains the same drug as the existing Vabysmo vials, but in a more handy, ready-to-use form and said that Roceh will continue to offer Vabysmo in 6.0 mg vials.

It is worthwhile to note here that Vabysmo is the first and only bispecific antibody licensed for use in the eye. Studies have demonstrated its immediate improvement in vision and its ability to reduce retinal swelling, a crucial factor as edoema can lead to distorted and blurred vision.

Over 95 countries, including the US and Japan, have already approved Vabysmo for nAMD and DME, as well as for RVO. The world has distributed over four million doses of Vabysmo since its first US clearance in 2022. Other health authorities around the world are doing an ongoing review. 

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