FDA Green Lights Genentech’s Vabysmo Prefilled Syringe for Three Causes of Vision Loss

The FDA has approved Genentech’s Vabysmo Prefilled Syringe (PFS) for treating wet AMD, DME, and RVO, offering a simplified administration option for retina specialists.

Key points:

  • Vabysmo PFS is the first FDA-approved prefilled syringe containing a bispecific antibody for retinal conditions.
  • The new format aims to enhance treatment experience for both physicians and patients by providing a ready-to-use option.
  • Vabysmo has demonstrated rapid and robust vision improvements and retinal drying in wet AMD, DME, and RVO.

Market estimate: Genentech’s Vabysmo competes against Regeneron Pharmaceuticals and Bayer’s Eylea, a macular degeneration treatment that generated $6.3 billion in U.S. sales in 2022 and $5.9 billion in 2023. Analysts project that Vabysmo will hit $3.3 billion in sales in 2024.

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Eye
Image Source: Pexels.com

The U.S. Food and Drug Administration (FDA) has given the green light to Genentech’s Vabysmo 6.0 mg single-dose prefilled syringe (PFS). This innovative medical device is indicated for patients with three leading causes of vision loss: wet age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO).

The Vabysmo PFS stands out as the first and only prefilled syringe containing an FDA-approved bispecific antibody designed to treat retinal conditions. This new format is expected to simplify administration for retina specialists, potentially improving the treatment experience for both healthcare providers and patients.

Dr. Levi Garraway, Genentech’s chief medical officer, expressed enthusiasm about the approval, stating, “This new offering should make it even simpler to administer, thereby enhancing the treatment experience for both physicians and patients.”

Vabysmo has already made significant strides in the market, with over four million doses distributed globally since its initial U.S. approval in 2022. The medication has demonstrated impressive results, showing rapid and robust vision improvements and retinal drying in patients with wet AMD, DME, and RVO.

Retina specialists and patients alike can look forward to the availability of Vabysmo PFS in the coming months, marking a new chapter in the fight against vision-threatening retinal conditions.

Vabysmo carton.

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