Roche announced one-year data from its Phase III MEERKAT and SANDCAT studies. The studies evaluated vamikibart, an investigational drug for uveitic macular edema (UME). UME is a leading cause of vision loss in people with uveitis. Roche presented these results at the American Academy of Ophthalmology 2026 Annual Meeting. Vamikibart provided sustained improvements in vision and reductions in macular thickness over 52 weeks.
Roche confirmed the U.S. Food and Drug Administration (FDA) accepted its Biologics License Application for vamikibart. The FDA expects a decision by July 2027. If approved, vamikibart would be the first non-steroid targeted therapy for UME. Regulatory submissions have also been accepted in the European Union, China, and Japan. The drug demonstrated a favorable safety profile and the potential for a low treatment burden.