Roche presents new Phase III pivotal data for vamikibart in UME

Roche (ROG: SIX) late Friday released results from two Phase III studies - dubbed MEERKAT and SANDCAT - evaluating the efficacy and safety of two doses of investigational vamikibart (0.25mg and 1mg) compared with a sham procedure that mimics intravitreal (IVT) injections in people with uveitic macular edema (UME).

The Swiss pharma giant noted that UME is characterized by the build-up of fluid in the macula due to uveitis, an inflammatory condition of the eye, that can result in vision loss. Across both studies, the primary and secondary endpoint data support the potential for rapid 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 annual meeting (AAO 2025) in Orlando, Florida, USA.

“The totality of data from these pivotal vamikibart studies represent an important step towards addressing a clear unmet need for people with uveitic macular edema,” said Dr Levi Garraway, Roche’s chief medical officer and head of global product development. “UME is a major cause of vision loss and blindness in people of working age. We look forward to discussing the data for this potential first-in-class treatment with regulatory authorities,” he added.