Faricimab for Polypoidal Choroidal Vasculopathy: 48-Week Results from the Phase 3b/4 SALWEEN Trial

Why clinicians should know about it

• Picked for Ophthalmology (paper of the day, 13 August 2026): Faricimab PCV trial, BCVA and CST outcomes

Abstract

OBJECTIVE: To evaluate the 48-week efficacy and safety results for faricimab in patients with polypoidal choroidal vasculopathy (PCV). DESIGN: SALWEEN (ISRCTN69073386) is a phase 3b/4, multicenter, open-label, single-arm, 108-week trial. PARTICIPANTS: Treatment-naïve patients aged ≥ 50 years with symptomatic macular PCV in Asia. METHODS: Patients received faricimab 6 mg every 4 weeks (Q4W) up to week 12 (loading period), Q8W-Q16W up to week 48, and Q8W-Q20W via a treat-and-extend-based dosing regimen up to week 104. Treatment intervals from week 20 were based on protocol-defined disease activity criteria, including change in central subfield thickness (CST) and best-corrected visual acuity (BCVA) and presence of new macular hemorrhage. MAIN OUTCOME MEASURES: Primary endpoint: BCVA change from baseline averaged over weeks 40/44/48. Selected secondary/exploratory endpoints through week 48: CST change from baseline; proportion of patients achieving absence of subretinal/intraretinal fluid (SRF/IRF), complete polypoidal lesion regression, and dosing interval assignment at the end of the loading period and week 48; and ocular/nonocular adverse events. RESULTS: Overall, 135 patients were enrolled across 38 sites in 9 countries/regions. Mean ± SD baseline BCVA and CST were 64.4 ± 11.3 letters and 417.0 ± 155.2 μm, respectively. Mean (95% CI) change from baseline to weeks 40/44/48 average was +8.9 (7.3-10.5) letters for BCVA and -126.5 (-144.8 to -108.3) μm for CST. The proportion of patients with absence of SRF/IRF increased from 13.5% (18/133) at baseline to 76.4% (97/127) at week 48. In patients with reading center-confirmed PCV lesions, 60.8% (59/97) had complete polypoidal lesion regression at week 48. At week 48, 83.4% (105/126) of patients were on ≥ Q12W dosing and 53.2% (67/126) were assigned to Q20W dosing. Faricimab was generally well tolerated through week 48. Safety data were consistent with the known safety profile of faricimab. CONCLUSIONS: Vision and anatomical improvements achieved during the loading phase were maintained through week 48 with patients on ≤ Q16W faricimab dosing. These data support the potential for dual angiopoietin-2/vascular endothelial growth factor-A inhibition with faricimab to extend treatment durability while maintaining vision and anatomic improvements, including complete polypoidal lesion regression, in patients with PCV.

Abstract as published, via PubMed.