Chugai’s Vabysmo Improves Vision, Reduces Retinal Fluid In NIHONBASHI Phase III Trial For Angioid Streaks

Chugai Pharmaceutical has presented positive Phase III results from the NIHONBASHI study of Vabysmo® (faricimab), a bispecific anti-VEGF/anti-Ang-2 antibody, for the treatment of angioid streaks associated with neovascularisation. The findings were shared at the 129th Annual Meeting of the Japanese Ophthalmological Society. The study enrolled 24 patients in Japan who initially received Vabysmo injections every four weeks for three doses, followed by as-needed dosing based on disease activity. 

“Based on the study results, Vabysmo is expected to become the first drug for angioid streaks, for which there are currently no approved drugs in Japan. The regulatory approval review is currently underway under priority review. Chugai will make every effort to obtain approval in Japan to deliver this drug to patients eagerly awaiting treatment as soon as possible,” said Chugai’s President and CEO, Dr. Osamu Okuda.

The trial achieved its primary endpoint, with patients experiencing a mean improvement in best-corrected visual acuity of +5.8 letters at week 12. The lower limit of the 90% confidence interval (3.0 to 8.5 letters) surpassed the predefined threshold, demonstrating statistically and clinically meaningful improvements. A key secondary outcome, the reduction in central retinal thickness, also showed a substantial average decrease of 106.4 µm, suggesting a significant reduction of fluid and swelling in the retina. 

Most patients experienced favourable treatment responses to Vabysmo because the drug displayed good tolerance and led to no severe eye-related complications. According to study results, only 20.8% of patients had adverse effects that affected their eyes, while 50% reported non-ocular adverse events, none of which were considered related to the treatment. The results matched prior studies of Vabysmo's safety information, demonstrating the compound's potential utility in treating this rare eye condition.