Roche Shares Vabysmo Trial Results

Roche has announced positive results from the Phase 3b/4 SALWEEN trial and the AVONELLE-X extension study of Vabysmo® (faricimab), presented at the 25th EURETINA Congress, held September 4–7 in Paris. The findings reinforce the safety, efficacy, and durability of faricimab in neovascular age-related macular degeneration (nAMD) and polypoidal choroidal vasculopathy (PCV), demonstrating meaningful improvements in visual outcomes and retinal anatomy.

Overview of AVONELLE-X Extension Study in Neovascular AMD

The AVONELLE-X study (NCT04777201) is a 2-year, open-label, multicenter extension trial involving 1,029 patients with nAMD, all of whom had previously participated in the pivotal Phase 3 TENAYA (NCT03823287) or LUCERNE (NCT03823300) studies.

Key Findings:

• Efficacy, safety, and durability of faricimab were reinforced over four years of treatment.

• By year four, nearly 80% of patients extended their treatment intervals to every 3 to 4 months, consistent with previous results from TENAYA and LUCERNE.

These findings further support faricimab’s potential to reduce treatment burden while maintaining long-term disease control in patients with nAMD.

Clinical Data from SALWEEN Study in PCV Population

The SALWEEN study is a Phase 3b/4, open-label, single-arm, multicenter trial designed to evaluate faricimab in Asian patients with polypoidal choroidal vasculopathy (PCV).

Key Findings:

• Participants experienced a clinically meaningful gain of 8.9 letters in BCVA from baseline, averaged over weeks 40, 44, and 48.

• More than 60% of patients had complete resolution of polyp-like lesions, with 86% of eyes showing inactivation of polypoidal lesions.

These results confirm faricimab’s efficacy in addressing the unique anatomical features of PCV, a subtype of neovascular AMD that is more prevalent in Asian populations.

Expert Commentary from Roche

“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 and Head of Global Product Development at Roche.

“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.”

About Faricimab (Vabysmo)

Faricimab is the first bispecific antibody approved for ocular use, targeting two key disease pathways, angiopoietin-2 (Ang-2) and VEGF-A. By simultaneously neutralizing both targets, faricimab is designed to stabilize blood vessels and reduce retinal inflammation and leakage.

Global Approvals

Faricimab is approved in over 100 countries, including the United States, Japan, the United Kingdom, and the European Union, for the treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME). It is also approved in more than 60 countries for the treatment of macular edema following retinal vein occlusion (RVO).