In AVONELLE-X, the largest long-term extension trial in wet AMD, disease control and durability were maintained over 4 years, with nearly 80% of patients on extended dosing by study end
Over 60% of people with a difficult-to-treat form of wet AMD showed no signs of damaging lesions in the SALWEEN study, and clinically meaningful vision improvements were observed
Vabysmo was well tolerated with a consistent long-term safety profile in wet AMD in both studies
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today new data from the AVONELLE-X and SALWEEN studies of Vabysmo® (faricimab-svoa), presented at the 25th Euretina Congress in Paris, France. Data from the open-label AVONELLE-X study reinforce the efficacy, safety and durability of Vabysmo over four years in wet age-related macular degeneration (AMD), a leading cause of vision loss. In the single-arm SALWEEN study, Vabysmo showed clinically meaningful vision gains and retinal drying over one year in polypoidal choroidal vasculopathy (PCV), a vision-threatening subtype of wet AMD that is especially common in Asia.
“The robust SALWEEN findings in PCV highlight Vabysmo’s potential to deliver clinically meaningful improvements and help mitigate vision loss,” said Levi Garraway, M.D., Ph.D., Genentech’s chief medical officer and head of Global Product Development. “Alongside the long-term AVONELLE-X results in wet AMD, these findings support our mission to develop and deliver impactful medicines for people with difficult-to-treat eye diseases.”
In new one-year data from the single-arm, open-label Phase IIIb/IV SALWEEN study of Vabysmo for the treatment of people with PCV in Asia, patients experienced a clinically meaningful gain of 8.9 letters in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44 and 48. At year 1, more than 50% of patients were assigned to extended five-month dosing. Vabysmo also had a clinically meaningful impact on the abnormal, polyp-like blood vessels characteristic of PCV, with these lesions completely resolving in more than 60% of patients and inactivation of polypoidal lesions in the majority (86%) of eyes. Vabysmo was well tolerated, with a safety profile in PCV that was consistent with its known safety profile in wet AMD.
The AVONELLE-X study was a two-year open-label extension of the two-year Phase III TENAYA and LUCERNE studies of Vabysmo in wet AMD. Vision remained stable throughout the two years of AVONELLE-X, and anatomic improvement from the parent trials was sustained through AVONELLE-X. Results showed that after up to four years of treatment with Vabysmo, nearly 80% of patients had extended their treatment intervals to every three or four months, reinforcing the results seen in TENAYA and LUCERNE. Vabysmo was well tolerated, and safety data were consistent with its known safety profile in wet AMD.
To date, Vabysmo is approved in more than 100 countries for wet AMD and diabetic macular edema (DME), and in more than 60 countries for macular edema following retinal vein occlusion (RVO). More than eight million doses of Vabysmo have been distributed globally since its initial U.S. approval in 2022.
