FDA Approves Genentech’s Vabysmo Prefilled Syringe to Treat Wet Age-Related Macular Degeneration, Diabetic Macular Edema, Macular Edema Following Retinal Vein Occlusion

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The FDA has approved Genentech’s Vabysmo (faricimab-svoa) 6.0 mg single-dose prefilled syringe (PFS) to treat patients with wet age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema following retinal vein occlusion (RVO). According to the company, the PFS format was developed to streamline the administration process, resulting in a smoother treatment experience for both physicians and patients. The PFS version of the treatment offers the same medication as the current Vabysmo vials in a ready-to-use form. Genentech noted that Vabysmo is the first bispecific antibody approved for the eye.¹

“We are pleased that the US 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,” said Levi Garraway, MD, PhD, chief medical officer, head of Global Product Development, Genentech, in a press release. “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.”

Vabysmo targets and inhibits two signaling pathways linked to a number of vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Currently, research is ongoing to understand the role of the Ang-2 pathway in retinal disease, with the hypothesis that Ang-2 and VEGF-A contribute to vision loss by destabilizing blood vessels.

The most common adverse events (AEs) reported in patients treated with Vabysmo were cataracts and blood on the white of the eye. Genentech warns that the treatment could pose a risk to unborn babies, further suggesting that patients should use birth control before, during, and for three months after their last dose of Vabysmo. Additionally, it is currently unknown whether Vabysmo passes into breast milk. It can also result in a temporary increase in pressure in the eye one hour after injection, can cause eye infections, retinal vasculitis, retinal vascular occlusion, and, in rare cases, fatal issues such as heart attacks or strokes.¹

Current treatments for macular degeneration include medical injections to the eye to prevent leaky blood vessels from forming, laser therapy, photodynamic therapy, submacular surgery, vitamins, and retinal translocation. It can be prevented through eating vegetables high in carotenoids, refraining from smoking, wearing sunglasses with an ultraviolet filter, and keeping up with visits to an eye care specialist.²

“Conventional treatment for disorders such as nearsightedness, farsightedness, and astigmatism typically relies on corrective prescription lenses,” reports WebMD. “Disorders such as cataracts, glaucoma, macular degeneration, and retinal detachment require advanced medical and surgical treatments. Enormous progress in eye surgery has been made over the past few decades. Many people with eye problems previously felt to be untreatable now enjoy improved eyesight and an improved quality of life.”

The Centers for Disease Control and Prevention (CDC) also recommends frequently washing hands before putting in contact lenses as well as cleaning them properly. Additionally, maintaining a healthy weight will help prevent the development of chronic conditions such as type 2 diabetes, which could result in eye damage. The CDC states that 90% of blindness caused by diabetes is avoidable by maintaining a health blood sugar level.³

Vabysmo, which was first approved in the United States in 2022, is approved in 95 countries for the treatment of wet AMD and DME, and in a number of countries for RVO as well. Currently, the treatment is under review by governing health agencies across the globe.¹

References

1. FDA Approves Genentech’s Vabysmo Prefilled Syringe (PFS) for Three Leading Causes of Vision Loss. Genentech. July 4, 2024. Accessed July 8, 2024. https://www.gene.com/media/press-releases/15030/2024-07-04/fda-approves-genentechs-vabysmo-prefille

2. Understanding Vision Problems – Treatment. WebMD. March 13, 2024. Accessed July 8, 2024. https://www.webmd.com/eye-health/understanding-vision-problems-treatment

3. Preventing Vision Loss. CDC. Accessed July 8, 2024. https://www.cdc.gov/vision-health/prevention/index.html