Chugai Files Vamikibart for Regulatory Approval in Japan for Uveitic Macular Edema
核心洞察
Chugai Pharmaceutical filed a regulatory application with Japan's Ministry of Health, Labour and Welfare for vamikibart, an anti-IL-6 monoclonal antibody, to treat uveitic macular edema (搜索) associated with non-infectious uveitis (搜索).
Vamikibart received orphan drug designation for this indication on June 23, 2026, and the filing is supported by the global Phase III MEERKAT and SANDCAT studies.
The Phase III trials evaluated vamikibart 0.25 mg and 1 mg versus sham intravitreal injection, with a primary endpoint of at least 15-letter BCVA improvement at Week 16.
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced on August 25, 2026, that it has filed a regulatory application with Japan's Ministry of Health, Labour and Welfare (MHLW) for vamikibart, an anti-IL-6 monoclonal antibody, for the treatment of uveitic macular edema (搜索) (UME) associated with non-infectious uveitis (搜索). The filing follows the MHLW's grant of orphan drug designation for vamikibart in this indication on June 23, 2026.
"Uveitic macular edema (搜索) associated with non-infectious uveitis (搜索) can lead to visual impairment and have a long-term impact on patients' lives. While corticosteroids have been the mainstay of treatment, we hope that vamikibart, an anti-IL-6 antibody, will enable patients to continue treatment with confidence and help preserve vision over the long term. We remain committed to obtaining approval as soon as possible so that patients can gain access to vamikibart at the earliest opportunity," said Chugai's President and CEO, Dr. Osamu Okuda.
Clinical Evidence Supporting the Filing
The regulatory application is based on results from the global Phase III MEERKAT and SANDCAT studies, among others, in patients with uveitic macular edema (搜索) associated with non-infectious uveitis (搜索). Development of vamikibart in Japan is conducted by Chugai, and Japan participated in the SANDCAT study.
The MEERKAT and SANDCAT studies are identically designed global Phase III, randomized, double-masked, sham-controlled clinical trials evaluating the efficacy and safety of vamikibart in patients with uveitic macular edema (搜索) associated with non-infectious uveitis (搜索). Patients were randomized to receive vamikibart 0.25 mg, vamikibart 1 mg, or sham intravitreal injection every four weeks for four doses, followed by dosing according to disease status.
The primary endpoint of both studies was the proportion of patients achieving an improvement of at least 15 letters from baseline in best corrected visual acuity (BCVA) at Week 16. Key secondary endpoints included mean change from baseline in BCVA and mean change from baseline in central subfield thickness (CST), a measure of macular edema, at Week 16.
Disease Background and Unmet Need
Uveitic macular edema (搜索) is characterized by the buildup of fluid in the macula, the center of the retina, due to uveitis, an inflammatory condition of the eye. Although rare compared with other eye diseases, uveitic macular edema has a disproportionate impact on vision loss and blindness globally. It is the leading cause of moderate to severe vision loss in people with uveitis and the most frequent sight-threatening complication in uveitis. Uveitis accounts for 10% to 20% of blindness in the United States and Europe, and up to 25% of blindness in the developing world.
Uveitic macular edema (搜索) has a significant negative impact on people's quality of life, including physical and mental health, social functioning, and visual function for day-to-day activities such as driving and reading. Steroid therapy is the current standard of care for uveitic macular edema associated with non-infectious uveitis (搜索), and the estimated number of patients in Japan is approximately 26,000.