Roche’s Vabysmo® Demonstrates Long-Term Efficacy In nAMD And Strong One-Year Results In Polypoidal Choroidal Vasculopathy (PCV)

Roche presented new data from its AVONELLE-X and SALWEEN studies of Vabysmo® (faricimab) at the 25th Euretina Congress in Paris. The findings reinforce Vabysmo’s long-term efficacy, safety, and durability in neovascular or “wet” age-related macular degeneration (nAMD) and show clinically meaningful benefits in polypoidal choroidal vasculopathy (PCV), a subtype of nAMD more common in Asia.

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

In the SALWEEN Phase IIIb/IV study of PCV patients in Asia, Vabysmo achieved an average 8.9-letter gain in vision at one year and over 50% of patients were extended to five-month dosing intervals. Importantly, more than 60% of patients had complete resolution of PCV lesions, and 86% achieved lesion inactivation, highlighting strong efficacy. Vabysmo was well tolerated, with a safety profile consistent with prior nAMD studies.

The AVONELLE-X trial, a two-year extension of the pivotal TENAYA and LUCERNE studies in nAMD, confirmed sustained vision stability and anatomical improvements for up to four years of treatment. Nearly 80% of patients were maintained on three- or four-month dosing schedules, demonstrating Vabysmo’s durable effect. To date, Vabysmo is approved in over 100 countries for nAMD and DME and in more than 60 countries for retinal vein occlusion-related macular edema, with over eight million doses delivered globally since its 2022 U.S. approval.