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Spotlight on VABYSMO®

Ophthalmology 360

This Spotlight Series article is editorially independent content.

Age-related macular degeneration (AMD) is the leading cause of visual impairment and blindness for individuals aged 60 years and older in the United States. Wet, or neovascular, AMD (nAMD) is an advanced form of the disease that can cause rapid and severe vision loss if left untreated. Between 18 and 20 million US adults are living with some form of AMD; of those, about 1.5 million have late-stage AMD, which includes neovascular AMD.1,2

VABYSMO® Targets Dual Pathways

The treatment landscape for neovascular AMD is continually advancing. In 2022, the FDA approved VABYSMO (faricimab-svoa; Genentech, a member of the Roche Group) for the treatment of neovascular AMD, marking the first bispecific antibody approved for the eye.3

VABYSMO targets and inhibits 2 signaling pathways linked to several vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). It is designed to stabilize blood vessels by blocking pathways involving Ang-2 and VEGF-A.1,4

Efficacy Data

The FDA approval was based on the results from 2 pivotal, randomized, multicenter, double-masked, active comparator-controlled, phase 3 studies (TENAYA and LUCERNE) in 1,329 patients with neovascular AMD. The head-to-head studies compared VABYSMO 6 mg versus aflibercept 2 mg.4,5

Both studies met their primary end point, with VABYSMO given at intervals of up to every 4 months consistently shown to offer visual acuity gains that were noninferior to aflibercept given every 2 months. In TENAYA and LUCERNE, the average best-corrected visual acuity (BCVA) from baseline at 1 year in the VABYSMO arms was +5.8 and +6.6 letters, respectively, versus +5.1 and +6.6 letters in the aflibercept arms.4,5

 AVONELLE-X and SALWEEN Studies

New data from the AVONELLE-X and SALWEEN studies showed positive efficacy, safety, and durability of VABYSMO, as well as meaningful vision gains and retinal drying.1,6,7

AVONELLE-X was an open-label, multicenter, 2-year extension study of VABYSMO in 1,029 patients with neovascular AMD who completed TENAYA or LUCERNE. After up to 4 years of treatment with VABYSMO, nearly 80% of patients had extended their treatment intervals to every 3 or 4 months, reinforcing the results observed in TENAYA and LUCERNE (see FIGURE 1).6

Additionally, 44% of patients with persistent retinal fluid on aflibercept 2 mg every 8 weeks experienced resolution 2 years after switching to VABYSMO.

SALWEEN was a phase 3b/4 multicenter, open-label, single-arm study of VABYSMO for the treatment of 135 Asian patients with polypoidal choroidal vasculopathy (PCV), a subtype of neovascular AMD that is more prevalent in people of Asian descent. Patients experienced a clinically meaningful gain of 8.9 letters in BCVA from baseline averaged over weeks 40, 44, and 48. VABYSMO was also associated with complete regression and inactivation of polypoidal lesions in most eyes at week 48 (see FIGURE 2).1,7

 Safety and Tolerability

VABYSMO demonstrated a favorable safety profile across studies. Rates of ocular adverse events (AEs) were comparable between VABYSMO and aflibercept (TENAYA, 36.3% vs 38.1%; LUCERNE, 40.2% vs 36.2%). The most common adverse reactions (≥1% of patients) included conjunctival hemorrhage, cataract, vitreous detachment, vitreous floaters, retinal pigment epithelial tears, increase in intraocular pressure, and eye pain.4,5

VABYSMO was well-tolerated through 2 years of the AVONELLE-X trial. AEs were consistent with the pivotal studies. In the SALWEEN study, VABYSMO was well-tolerated through week 48, with a safety profile in PCV that was consistent with its known safety profile in neovascular AMD.6,7

Dosing and Administration

VABYSMO offers flexible 1– to 4–month dosing for the treatment of neovascular AMD. The recommended dose is a 6-mg intravitreal injection every 4 weeks for the first 4 doses. Following this loading phase, optical coherence tomography and visual acuity assessments are conducted at weeks 8 and 12 to determine the appropriate ongoing dosing schedule administered either every 8, 12, or 16 weeks.

For more information, visit www.vabysmo-hcp.com.

References

  1. New data for Genentech’s Vabysmo reinforce its efficacy, safety and durability in neovascular or “wet” age-related macular degeneration (nAMD). News release. Genentech. September 5, 2025. Accessed October 9, 2025. https://www.biospace.com/press-releases/new-data-for-genentechs-vabysmo-reinforce-its-efficacy-safety-and-durability-in-wet-age-related-macular-degeneration-amd
  2. Sugue M. Age-related macular degeneration statistics 2025. Vision Center. Updated April 30, 2025. Accessed October 9, 2025. https://www.visioncenter.org/resources/amd-prevention-statistics/
  3. FDA approves Roche’s Vabysmo, the first bispecific antibody for the eye, to treat two leading causes of vision loss. News release. Roche. January 30, 2022. Accessed October 9, 2025. https://www.roche.com/media/releases/med-cor-2022-01-31
  4. Package insert. Genentech Inc; 2024.
  5. Heier JS, Khanani AM, Quezada Ruiz C, et al; ENAYA and LUCERNE Investigators. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. 2022;399(10326):729-740. doi:10.1016/S0140-6736(22)00010-1
  6. Sheth V, Patel S, Khanani AM, et al. Four-year outcomes of faricimab in nAMD: safety and efficacy results from the AVONELLE-X long-term extension trial. Presented at the 25th EURETINA Congress; September 4-7, 2025; Paris, France.
  7. Lai TY, Chen SJ, Lida T, et al. Faricimab for polypoidal choroidal vasculopathy: 1-year results from the Phase 3b/4 SALWEEN trial. Presented at the 25th EURETINA Congress; September 4-7, 2025; Paris, France.

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