The Phase IIIb/IV SALWEEN data showed improvement in BCVA, drying and polypoidal lesion reduction in Asian patients.
Roche (Basel, Switzerland) announced promising interim data on Friday for its anti-VEGF drug faricimab in treating patients with polypoidal choroidal vasculopathy (PCV), a form of neovascular age-related macular degeneration.
The data, taken from its ongoing Phase IIIb/IV SALWEEN trial, revealed that faricimab showed significant reduction in polypoidal lesions and improvement in vision in Asian patients with PCV.1
PCV is a complex and aggressive form of nAMD and is a major cause of vision loss, particularly in East and Southeast Asia, where it represents about 50% of all nAMD cases.2
The findings were disclosed at the 17th Congress of the Asia-Pacific Vitreo-Retina Society (APVRS 2024) in Singapore from 22 to 24 November.
Professor Gemmy Cheung, head of retina research at the Singapore Eye Research Institute (SERI), commented on the results and what they could mean for patients suffering from the disease.
“PCV has historically been more challenging to treat, with less predictable outcomes compared to typical neovascular age-related macular degeneration,” she said in a news release. “Given that PCV accounts for about half of all nAMD cases in Asian populations, and up to 20% in Caucasian populations, the SALWEEN trial is a significant step forward in our understanding of how to manage this condition.”
Building on the success of the TENAYA and LUCERNE studies for faricimab in nAMD, the SALWEEN trial is focused specifically on PCV—offering clinicians insights in how to tailor treatments with the agent for these patients.
“By addressing key scientific questions—such as how polypoidal lesions respond to faricimab and the role of the angiopoietin-Tie2 pathway—we are advancing our understanding of how best to manage this complex condition,” Prof. Cheung added.
Area Head for Asia Pacific at Roche Pharmaceuticals, Ahmed Elhusseiny, emphasized the importance of addressing this growing health challenge.
“With nearly two-thirds of global vision loss concentrated in the Asia Pacific, advancing treatments for this region is essential. These early results from the SALWEEN trial are promising and highlight Vabymo’s potential to significantly improve outcomes for people with PCV.”
Interim result highlights from the SALWEEN trial
The study found that faricimab proved successful in three key areas for those affected by PCV at the 16-week mark.
- Resolution of Polypoidal Lesions: 51% of patients with PCV experienced a complete disappearance of polypoidal lesions—abnormal blood vessels that are characteristic of the disease. The resolution of these lesions is particularly notable, as it suggests a restoration of retinal health and could potentially prevent further vision deterioration.
- Improvement in Vision: Patients treated with faricimab gained an average of +7.8 letters on a standard visual acuity test, equivalent to reading about one and a half additional lines on an eye chart.
- Reduction in Retinal Fluid: 80% of patients receiving faricimab showed no detectable retinal fluid, indicating that the therapy effectively reduces the harmful fluid buildup that contributes to the disease’s progression.1
SALWEEN study design
The SALWEEN study, conducted across several Asian countries including China, Japan and South Korea, includes 135 patients aged 50 and older. During the first 12 weeks, patients received four monthly loading doses of Vabysmo, with subsequent doses tailored to each patient’s response.
The ongoing SALWEEN trial aims to assess the effectiveness of Vabysmo in patients with PCV. Vabysmo, a dual-action therapy, is designed to target two key pathways—VEGF-A and angiopoietin-2 (Ang-2)—which play a major role in abnormal blood vessel formation and retinal fluid leakage, both of which contribute to the progression of diseases like PCV.
The final results from the SALWEEN trial are expected in 2026, which will provide further insights into the long-term efficacy and safety of Vabysmo for the treatment of PCV.
References
- Cheung CMG et al. Faricimab for Polypoidal Choroidal Vasculopathy: Week 16 Results From the Phase 3b/4 SALWEEN Trial. Available at: https://2024.apvrs.org/abstract/?code=200756 Accessed on 21 November 2024
- Cheung CMG, Lai TYY, Ruamviboonsuk P, et al. Polypoidal Choroidal Vasculopathy: Definition, Pathogenesis, Diagnosis, and Management. Ophthalmology. 2018;125(5):708-724.
