Faricimab Succeeds in AVONELLE-X and SALWEEN Trials for nAMD, With Veeral Sheth, MD

Positive results from the AVONELLE-X and SALWEEN studies of faricimab (Vabysmo) have reinforced the safety, efficacy, and durability over 4 years in neovascular age-related macular degeneration (nAMD) and over 1 year in polypoidal choroidal vasculopathy (PCV), respectively.1

AVONELLE-X was a 2-year open-label extension of the 2-year phase 3 TENAYA and LUCERNE studies of faricimab in nAMD. The trial evaluated the long-term safety and tolerability of faricimab 6 mg, administered via intravitreal injection and at a personalized treatment interval (PTI).2

Patients eligible for AVONELLE-X had to have completed either the TENAYA or LUCERNE trial and displayed a difference of <10% in corneal endothelial cell density at screening between both eyes. Patients were excluded if they were pregnant or breastfeeding, had other ocular diseases conferring reasonable suspicion of a disease contraindicating faricimab, had a history of severe allergic reaction or anaphylactic reaction to a biologic agent of the faricimab injections, or were required to continuously use a medication or treatment prohibited by the investigators.2

The editorial team at HCPLive sat down with Veeral Sheth, MD, director of clinical research at the University of Retina and Macula Associates and clinical assistant professor at the University of Illinois, to discuss the results of these groundbreaking trials. Sheth noted the positive vision outcomes of AVONELLE-X, spotlighting the overall maintenance of vision quality.

“One piece of data I thought was really good coming out of this extension is that, when patients were at 20/40 vision or better at year 1, after treating those patients and fast-forwarding to now, at the end of year 4, 75% of those patients maintain 20/40 or better vision,” Sheth told HCPLive. “This is incredible because that’s something you can immediately translate into how we talk to our patients who come in newly diagnosed.”

SALWEEN was a single-arm, open-label phase 3b/4 study of faricimab in patients with PCV in Asia. It consists of a 28-day screening period and 3 treatment periods: a treatment initiation period (Day 1-Week 12), an individualized constant treatment interval period (Week 20-Week 44/48), and a PTI period (Week 44/48-Week 104). Patients first received 4 doses of faricimab 6 mg, injected in the study eye every 4 weeks. Patients would then receive faricimab 6 mg injections into the study eye at variable intervals, every 4, 8, 12, 16, or 20 weeks.3

Patients included in SALWEEN experienced a gain of 8.9 letters in best-corrected visual acuity (BCVA) from baseline, averaged over weeks 40, 44, and 48. At year 1, >50% of patients were assigned to extended 5-month dosing. Additionally, faricimab resolved PCV-related lesions in >60% of patients and led to inactivation of polypoidal lesions in 86% of eyes. Faricimab also exhibited a safety profile consistent with its known safety profile in nAMD.1

Sheth highlighted excellent vision outcomes and significant dose extension in SALWEEN, which is a common theme among upcoming ophthalmology treatments in recent years.

“PCV is traditionally more difficult to treat and control and get resolution than typical or standard neovascular AMD,” Sheth said. “These patients did very well in terms of disease control, in terms of vision outcomes, and a majority of patients were actually able to get out to 24-week dosing intervals.”

References

1. Roche. New data for Roche’s Vabysmo reinforce its efficacy, safety and durability in neovascular or “wet” age-related macular degeneration (nAMD). September 4, 2025. Accessed October 21, 2025. https://www.roche.com/media/releases/med-cor-2025-09-05

2. Hoffmann-La Roche. A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (AVONELLE-X). ClinicalTrials.gov identifier: NCT04777201. Updated December 11, 2024. Accessed October 21, 2025. https://www.clinicaltrials.gov/study/NCT04777201?term=NCT04777201&rank=1

3. A study evaluating the effectiveness and safety of Faricimab (RO6867461) in participants with polypoidal choroidal vasculopathy. http://isrctn.com/. Published online September 22, 2022. doi:10.1186/isrctn69073386