Roche reported one-year results from its Phase III MEERKAT and SANDCAT studies of vamikibart, an investigational eye injection for uveitic macular edema (UME). Presented at the American Academy of Ophthalmology 2026 Annual Meeting, the data showed sustained improvements in vision and reductions in retinal thickness over 52 weeks.
The U.S. Food and Drug Administration (FDA) has accepted Roche’s Biologics License Application (BLA) for vamikibart. A decision on approval is expected by July 2027.
If approved, vamikibart would be the first non-steroid targeted therapy for UME, a significant cause of vision loss. Roche made the announcement over a weekend, so no immediate market reaction was available.