Roche announced compelling long-term data for Vabysmo (faricimab) at the 25th Euretina Congress in Paris, demonstrating sustained efficacy and safety over four years in neovascular age-related macular degeneration (nAMD) and clinically meaningful outcomes in a difficult-to-treat Asian subtype of the disease.
Four-Year Durability Confirmed in Largest nAMD Extension Study
The AVONELLE-X study, representing the largest long-term extension trial in nAMD, enrolled 1,029 patients who completed the Phase III TENAYA or LUCERNE studies. Results showed that disease control and durability were maintained over four years, with nearly 80% of patients achieving extended dosing intervals of every three or four months by study end.
"Vision remained stable throughout the two years of AVONELLE-X and anatomic improvement from the parent trials were sustained," according to the study findings. The treat-and-extend regimen allowed clinicians to adjust treatment intervals based on retinal fluid levels and visual acuity, demonstrating the drug's flexibility in real-world clinical practice.
Breakthrough Results in Asian PCV Population
The single-arm SALWEEN study provided the first comprehensive data on Vabysmo's efficacy in polypoidal choroidal vasculopathy (PCV), a vision-threatening subtype of nAMD that accounts for up to 60% of nAMD cases in people of Asian descent. The study enrolled 135 patients aged 50 years and over from 38 sites across nine Asian markets, including China, Hong Kong, India, Japan, Malaysia, Singapore, South Korea, Taiwan, and Thailand.
Patients experienced a clinically meaningful gain of 8.9 letters in best-corrected visual acuity from baseline, averaged over weeks 40, 44, and 48. More than 60% of patients showed complete resolution of the abnormal, polyp-like blood vessels characteristic of PCV, while inactivation of polypoidal lesions occurred in 86% of eyes.
"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, Roche's chief medical officer and head of Global Product Development.
Extended Dosing Intervals Achieved
Both studies demonstrated Vabysmo's ability to extend treatment intervals significantly. In SALWEEN, more than 50% of patients were assigned to extended five-month dosing at year one, with the protocol allowing for personalized treatment plans with doses spaced as far as every 20 weeks from weeks 44 to 104.
Consistent Safety Profile Maintained
Across both studies, Vabysmo demonstrated a well-tolerated safety profile consistent with its known safety characteristics in nAMD. The long-term safety data from AVONELLE-X, spanning up to four years of treatment, reinforces the drug's established safety record.
Global Impact and Market Position
Vabysmo, the first bispecific antibody approved for the eye, targets both angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A) pathways. The drug is currently approved in more than 100 countries for nAMD and diabetic macular edema, and in more than 60 countries for macular edema following retinal vein occlusion.
Since its initial US approval in 2022, more than eight million doses of Vabysmo have been distributed globally, underscoring its significant clinical adoption. The drug addresses a substantial unmet need, as nAMD affects approximately 20 million people worldwide and represents the leading cause of vision loss in people over age 60.
Addressing Unmet Needs in Retinal Disease
The SALWEEN results are particularly significant given that PCV presents unique challenges in treatment, especially in Asian populations where it is more prevalent. Early diagnosis and treatment are crucial for preventing vision loss in this condition, which is characterized by abnormal blood vessels in the choroid that can leak fluid or blood, leading to retinal damage.
These latest findings support Vabysmo's position in Roche's comprehensive ophthalmology pipeline, which the company describes as "the broadest retina pipeline in ophthalmology." The data reinforces the potential for extended dosing regimens that could reduce treatment burden while maintaining therapeutic efficacy in challenging retinal conditions.
