News|Articles|September 12, 2025

Vabysmo Shows Long-Term Efficacy and Safety in Wet AMD, PCV Patients

Results from the two-year AVONELLE-X extension study (NCT04777201) and the Phase IIIb/IV SALWEEN trial showed that Roche’s Vabysmo demonstrated durable vision improvements, extended dosing potential, and reliable safety treating wet age-related macular degeneration and polypoidal choroidal vasculopathy.

Topline Findings

Vabysmo efficacy in wet age-related macular degeneration (nAMD) and polypoidal choroidal vasculopathy (PCV): Clinical trials AVONELLE-X and SALWEEN indicate Vabysmo delivers meaningful vision improvements in patients with nAMD and PCV.

Extended Dosing Intervals: Up to four years of treatment allowed nearly 80% of nAMD patients and over 50% of PCV patients to extend Vabysmo dosing to three, four, or five months, reducing injection frequency while maintaining outcomes.

Global Impact on Vision Care: With PCV accounting for up to 60% of nAMD cases in Asia and nAMD affecting an estimated 20 million people worldwide, Vabysmo addresses a significant unmet need in long-term vision management.

Results from the AVONELLE-X extension study (NCT04777201) and the Phase IIIb/IV SALWEEN trial showed that Roche’s Vabysmo (faricimab) demonstrated notable improvements in patients with wet age-related macular degeneration (nAMD) and polypoidal choroidal vasculopathy (PCV). According to the company, Vabysmo represents a meaningful advance in the treatment of these conditions, helping to address unmet needs in vision care and supporting long-term disease management.¹

How Effective is Vabysmo in Addressing Difficult-to-Treat Forms of Macular Degeneration?

“The robust SALWEEN findings in PCV highlight Vabysmo’s potential to deliver clinically meaningful improvements and help mitigate vision loss,” said Levi Garraway, MD, PhD, chief medical officer, head of global product development, Roche, in a press release.

AVONELLE-X Extension Study in nAMD

The open-label, multicenter AVONELLE-X trial evaluated the long-term safety and tolerability of Vabysmo in 1,036 patients with nAMD who completed one of the two Phase III studies, TENAYA(NCT03823287) or LUCERNE (NCT03823300).
In the TENAYA and LUCERNE trials, patients received either 6 mg of Vabysmo or 2 mg of aflibercept.
All patients were switched to Vabysmo under a treat-and-extend approach, with intervals between doses tailored according to changes in retinal fluid and vision.
The primary endpoints of the trial were incidence and severity of ocular adverse events (AEs), incidence and severity of systemic AEs, and percent change in corneal endothelial cell density from baseline at one year.
The key secondary endpoint was percent change in corneal endothelial cell density from baseline at week 24.2
Results showed that following up to four years of Vabysmo therapy, almost 80% of patients were able to lengthen their dosing intervals to every three or four months.
Vabysmo was found to be well tolerated in the study, with no new safety signals identified.

SALWEEN Trial in PCV

The multicenter, open-label, single-arm SALWEEN trial evaluated Vabsymo in 135 patients aged 50 years and older with PCV.
Patients initially received four 6 mg loading doses of Vabysmo over 12 weeks.
Following this, their dosing schedule was tailored based on individual response, with intervals of eight, 12, or 16 weeks.
Between weeks 44 and 104, treatment was personalized further, with some patients receiving doses as infrequently as every 20 weeks.
The primary endpoint of the trial was the change from baseline in best-corrected visual acuity (BCVA) over weeks 40 to 48.
After one year of treatment, patients experienced a clinically meaningful improvement of 8.9 letters in BCVA, averaging over weeks 40, 44, and 48.
Over 60% of patients achieved complete resolution of polypoidal lesions, and 86% showed inactivation of these lesions.
More than 50% of patients were assigned to extended dosing intervals of five months, reducing the frequency of injections while maintaining vision outcomes.
The safety profile of Vabysmo in this study was consistent with its known safety profile in nAMD.

nAMD and PCV Global Context

According to Roche, PCV accounts for up to 60% of nAMD cases in people of Asian descent and up to 20% in people of European descent.
Currently, an estimated 20 million people are living with nAMD globally.
nAMD is also currently the leading cause of vision loss in people over 60 years of age.
As the global population ages, it is expected that the prevalence of nAMD will increase as well.¹

“Alongside the long-term AVONELLE-X results in nAMD, these findings support our mission to develop and deliver impactful medicines for people with difficult-to-treat eye diseases,” concluded Garraway, in the press release.

References

New data for Roche's Vabysmo reinforce its efficacy, safety and durability in neovascular or “wet” age-related macular degeneration (nAMD). Roche. September 4, 2025. Accessed September 11, 2025. https://www.roche.com/media/releases/med-cor-2025-09-05
A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (AVONELLE-X). Clinicaltrials.gov. Accessed September 11, 2025. https://clinicaltrials.gov/study/NCT04777201?term=NCT04777201&rank=1

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