Roche: Vabysmo shows two‑year efficacy and extended dosing in PCV (SALWEEN)
- SALWEEN (Phase IIIb/IV) enrolled 135 Asian patients with polypoidal choroidal vasculopathy across nine markets.
- Mean best‑corrected visual acuity gain was 7.3 letters and central subfield thickness fell by 127 µm averaged over weeks 100–108.
- At year two, 74% of patients had no retinal fluid; polypoidal lesion complete regression was 62% and inactivation 86%.
- Dosing durability increased from 51% of patients on a 20‑week interval at year one end to 61% by the end of year two.
Study and population
SALWEEN was an open‑label Phase IIIb/IV study of Vabysmo (faricimab) in 135 Asian patients aged ≥50 with polypoidal choroidal vasculopathy (PCV), run across 38 sites in nine Asian markets. Results were presented at the 19th Asia‑Pacific Vitreo‑retina Society (APVRS) Congress.
Efficacy outcomes
Across weeks 100–108 patients averaged a 7.3‑letter gain in best‑corrected visual acuity (BCVA) and a 127 µm reduction in central subfield thickness (CST). At year two, 74% had no retinal fluid. Polypoidal lesions showed 62% complete regression and 86% inactivation.
Durability and dosing
Patients received four loading doses over 12 weeks, then individualized intervals (8/12/16 weeks) with personalised extension up to 20 weeks from weeks 44–104. The proportion on a 20‑week interval rose from 51% at the end of year one to 61% at the end of year two, indicating reduced treatment burden.
Safety and mechanism
Vabysmo— a bispecific antibody that neutralises angiopoietin‑2 (Ang‑2) and VEGF‑A—was reported as well tolerated with a long‑term safety profile in line with its known profile for nAMD.
Source: Roche