Roche Presents New Clinical Data for Potential Macular Edema Treatment as US FDA Accepts Application

02:00 AM EDT, 10/11/2026 (MT Newswires) -- Roche (RO.SW) delivered new one-year data investigating vamikibart as a treatment for uveitic macular edema, or UME, and received an acceptance notice from the US Food and Drug Administration for the injection's biologics license application. In phase III meerkat and sandcat studies of vamikibart, compared with a sham procedure mirroring intravitreal injections in adults with UME, the Swiss drugmaker saw the potential for "rapid and sustained" improvements in vision and a decrease in macular thickness or swelling with vamikibart, according to an Oct. 10 release. Meanwhile, the FDA accepted the biologics license application for vamikibart to treat UME based on the results of the meerkat and sandcat studies. The FDA's decision on approval is expected by July 2027. Roche's regulatory submissions have also been accepted in the European Union, China, and Japan.