Positive topline data announced from AVONELLE-X and SALWEEN trials

Roche recently announced new data from the AVONELLE-X and SALWEEN trials of Vabysmo (faricimab).¹ These trial data were presented at the 25^th European Society of Retina Specialists (EURETINA) Annual Congress held September 4-7 in Paris. Positive safety, efficacy, and durability, as well as meaningful vision gains and retinal drying, were found between the two studies.

AVONELLE-X (NCT04777201) was an open-label, multicenter, 2-year extension study following 1,029 patients with neovascular age-related macular degeneration (nAMD), all of whom participated in one of the two phase 3 studies, TENAYA (NCT03823287) or LUCERNE (NCT03823300).¹ Data from AVONELLE-X demonstrated and reinforced the efficacy, safety, and durability of faricimab over four years in nAMD.¹ Results of AVONELLE-X showed that after up to four years of treatment with faricimab, nearly 80% of patients extended their treatment intervals to every 3 to 4 months, which was also seen in TENAYA and LUCERNE.¹

The phase 3b/4 multicenter, open-label, single-arm study, SALWEEN, evaluated faricimab for the treatment of Asian people with polypoidal choroidal vasculopathy (PCV). It demonstrated a clinically meaningful gain of 8.9 letters in best-corrected visual acuity (BCVA) from baseline averaged of weeks 40, 44, and 48. Faricimab was also found to have 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.¹

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

“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.”

Faricimab is the first bispecific antibody approved for the eye, targeting two signaling pathways linked to several vision-threatening retinal conditions by neutralizing angiopoietin-2 (Ang-2) and VEGF-A.¹ It is designed to stabilize blood vessels by blocking pathways involving Ang-2 and VEGF-A. Faricimab is approved in more than 100 countries, including the United States (US), Japan, the United Kingdom, and the European Union (EU), for the treatment of nAMD and diabetic macular edema (DME). It is additionally approved in more than 60 countries, including the US, EU, and Japan, for the treatment of macular edema following retinal vein occlusion (RVO).

Reference:

1. New data for Roche’s Vabysmo reinforce its efficacy, safety and durability in neovascular or “wet” age-related macular degeneration (nAMD). Roche.com. Published 2025. Accessed September 8, 2025. https://www.roche.com/media/releases/med-cor-2025-09-05