Chugai files vamikibart in Japan for uveitic macular edema
- Chugai submitted a regulatory application for vamikibart to Japan’s Ministry of Health, Labour and Welfare on August 25, 2026.
- Vamikibart received orphan drug designation in Japan on June 23, 2026 and has orphan status in the US as well.
- The filing is based on global Phase III MEERKAT and SANDCAT trials; Japan participated in the SANDCAT study.
- If approved, vamikibart would be the first intravitreal anti‑IL‑6 antibody therapy in Japan for uveitic macular edema and offer a non‑steroid local ocular option.
Regulatory action
Chugai has filed for marketing approval of vamikibart with Japan’s Ministry of Health, Labour and Welfare. The molecule holds orphan‑drug designation in Japan (granted June 23, 2026) and in the United States.
Clinical evidence
The submission is supported by data from the global, identically designed Phase III MEERKAT and SANDCAT trials, which randomized patients to intravitreal vamikibart 0.25 mg, 1 mg, or sham every four weeks for four doses, then dosing per disease status. The primary endpoint for both studies was the proportion of patients gaining ≥15 letters in best corrected visual acuity at Week 16; key secondaries included mean BCVA change and change in central subfield thickness.
Drug profile
Vamikibart is an anti‑interleukin‑6 monoclonal antibody engineered for intravitreal administration that targets the IL‑6 pathway implicated in inflammatory macular edema.
Disease context and need
Uveitic macular edema is fluid accumulation in the macula caused by uveitis and is a leading cause of vision loss in uveitis. Current standard treatment is steroid therapy; the proposed indication targets an estimated ~26,000 patients in Japan and aims to provide a non‑steroid, local treatment option to preserve vision long term.
Source: Chugai Pharmaceutical
