In Japanese Study, Vabysmo Achieves Primary Endpoint in Phase 3 Study for Angioid Streaks
Japan-based Chugai Pharmaceutical announced that the Japanese phase 3 study (NIHONBASHI study), evaluating Roche and Genentech's Vabysmo (faricimab) for angioid streaks associated with neovascularization, met its primary endpoint, demonstrating statistically significant and clinically meaningful vision improvement at 12 weeks. Vabysmo was generally well-tolerated and no new safety signal of this combination were observed.
The NIHONBASHI study investigated Vabysmo in 24 patients with angioid streaks and neovascularisation. The primary endpoint was the change in BCVA score from baseline at 12 weeks. Secondary endpoints included the mean change in BCVA score at 52 weeks, change in central subfield thickness from baseline over time, and safety.
The data will be submitted to health authorities in Japan, where the study was conducted, and will be presented at an upcoming medical meeting.
“I am very pleased that Vabysmo demonstrates good vision improvement for the first time in Japanese in clinical study for angioid streaks, a rare disease with no approved drugs in Japan. We will make efforts for filing for approval to deliver this drug to patients as soon as possible,” said Chugai’s President and CEO, Dr. Osamu Okuda.
