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FDA approval
Roche receives US FDA approval for Vabysmo PFS to treat retinal conditions
Longevity Tech
Jul 5, 2024
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Longevity Tech

Longevity Tech

Jul 5, 2024

Roche receives US FDA approval for Vabysmo PFS to treat retinal conditions

FDA approval

  • Roche has received US FDA approval for Vabysmo, an antibody-filled preloaded syringe, to treat neovascular or "wet" age-related macular degeneration (nAMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). Although pricing details were not disclosed, the product will be available soon.

  • Vabysmo, also known as "faricimab," is the only bispecific antibody approved for treating the eye. The company claims that it has demonstrated rapid and robust vision improvements and retinal drying in nAMD, DME, and RVO. This single-use preloaded syringe can be readily used by retina specialists.

  • Analyst QuickTake: To date, Vabysmo has been approved in over 95 countries for nAMD and DME, and many other countries including the US and Japan for RVO. Several other health authorities worldwide are reviewing the product for approval. Over 4 million doses of Vabysmo have been distributed globally since its initial US approval in 2022.

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