Roche announced new 2-year data from the phase 3b/4 SALWEEN study of Vabysmo (faricimab), presented at the 19th Asia-Pacific Vitreo-retina Society Congress in Australia. The results showed significant improvements in vision and retinal health in patients with polypoidal choroidal vasculopathy (PCV), a severe subtype of neovascular age-related macular degeneration (nAMD), the company said in a press release.
The study showed that patients experienced a gain of 7.3 letters in best-corrected visual acuity (BCVA) and a reduction of 127 µm in central subfield thickness from baseline averaged over weeks 100 to 108. At year 2, 74% of patients had no retinal fluid. Vabysmo also had a clinically meaningful impact on the abnormal, polyp-like blood vessels characteristic of PCV, with complete regression (62%) and inactivation (86%) of polypoidal lesions in the majority of eyes.
At the end of the first year, 51% of patients were assigned to extended 20-week dosing, which increased to 61% by the end of year 2. Vabysmo was well tolerated, with a safety profile in PCV that was consistent with its known safety profile in nAMD, the company said in the press release.
SALWEEN was a phase 3b/4 multicenter, open-label, single-arm study of Vabysmo for the treatment of Asian people with PCV. It enrolled 135 patients aged 50 years and over from 38 sites across 9 markets in Asia, including China, Hong Kong SAR, India, Japan, Malaysia, Singapore, South Korea, Taiwan, and Thailand. Patients received 4 loading doses of Vabysmo 6 mg over 12 weeks. After that, their treatment schedule was adjusted based on their progress, with doses given every 8, 12, or 16 weeks. From weeks 44 to 104, patients followed a personalized treatment plan with treatment intervals extended up to 20 weeks. The primary endpoint was the change from baseline in BCVA averaged over weeks 40 to 48. RP