Roche has announced new one-year data from phase 3 studies evaluating investigational vamikibart compared with a sham procedure that mimics intravitreal (IVT) injections in adults with uveitic macular oedema (UME).
Across two studies, data continue to support the potential for rapid and sustained improvements in vision and reductions in macular thickness (swelling in the back of the eye due to retinal fluid) with vamikibart treatment.
The data were presented at the American Academy of Ophthalmology 2026 Annual Meeting (AAO 2026) in New Orleans, LA.
Additionally, the US Food and Drug Administration (FDA) has accepted Roche’s Biologics License Application (BLA) for vamikibart for the treatment of UME. The filing acceptance is based on the results from the studies. The FDA is expected to make a decision on approval by July 2027.
If approved, vamikibart would be the first non-steroid targeted treatment for UME, with potential to establish a new standard of care. Regulatory submissions have also been filed and accepted in the European Union, China and Japan.
