Chugai Seeks Approval in Japan for Vabysmo to Treat Angioid Streaks
核心洞察
Chugai Pharmaceutical has filed for an additional indication in Japan for Vabysmo to treat angioid streaks (搜索) associated with neovascularization (搜索).
The application is based on positive results from the Phase III NIHONBASHI study, which demonstrated vision improvement in patients.
Angioid streaks (搜索), a rare disease with limited treatment options, can cause vision loss due to choroidal neovascularization (搜索).
Chugai Pharmaceutical Co., Ltd., a subsidiary of Hoffmann-La Roche, has announced the submission of an application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for an additional indication for Vabysmo (faricimab) intravitreal injection for the treatment of angioid streaks (搜索) associated with neovascularization (搜索). This application has been granted orphan drug designation by the MHLW and will undergo priority review.
Dr. Osamu Okuda, Chugai’s president and CEO, stated, “Angioid streaks (搜索) is a rare disease with no approved products in Japan. We will continue to work for approval as soon as possible so that Vabysmo, which demonstrated vision improvement in a Japanese phase III study, can contribute to the treatment of patients as a new option for angioid streaks.”
NIHONBASHI Study Results
The application is supported by data from the Phase III NIHONBASHI study, a multicenter, single-arm trial conducted in Japan. The study enrolled 24 patients with angioid streaks (搜索) associated with neovascularization (搜索) to evaluate the efficacy and safety of Vabysmo. The primary endpoint was the change in best-corrected visual acuity (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.
Angioid Streaks and Current Treatment Landscape
Angioid streaks (搜索) are characterized by cracks in the retina, leading to pigmented streaks in the fundus. While often asymptomatic, the condition can lead to decreased or distorted vision when choroidal neovascularization (搜索) extends to the macula. Current treatments, including surgery and laser therapy, have limited effectiveness, highlighting the need for new therapeutic options. It is estimated that approximately half of patients with pseudoxanthoma elasticum (an intractable disease) also have angioid streaks.
Vabysmo: A Bispecific Antibody Approach
Vabysmo is the first bispecific antibody approved for ophthalmic use. It functions by neutralizing both angiopoietin-2 (Ang-2 (搜索)) and vascular endothelial growth factor-A (VEGF-A (搜索)), two signaling pathways implicated in vision-threatening retinal conditions. By inhibiting these pathways, Vabysmo aims to stabilize blood vessels, reduce the formation of new leaky blood vessels, and decrease inflammation. The drug is already approved in nearly 100 countries, including the US, Japan, the UK, and the EU, for neovascular age-related macular degeneration and diabetic macular edema (搜索), and in several countries for macular edema following retinal vein occlusion.