Roche presents new phase III p... Note

Roche presents new phase III pivotal data for vamikibart in uveitic macular edema (UME), a serious cause of vision loss

Roche announced results from two phase III studies, MEERKAT and SANDCAT, evaluating vamikibart for uveitic macular edema (UME). Vamikibart is a non-steroid targeted therapy targeting IL-6, the primary inflammatory pathway in UME. Both studies assessed two doses of vamikibart compared to sham injections, with vision improvements observed. The MEERKAT trial showed statistically significant superiority over the sham, while SANDCAT results were nominally significant. Secondary endpoints consistently showed improvements in visual acuity and reduced macular thickness. Vamikibart was generally well tolerated, with a low incidence of ocular adverse events. The primary outcome was based on improvement in best corrected visual acuity. The data from these studies will be discussed with regulatory authorities globally. These trials included patients with varying characteristics, which may have impacted outcomes. UME is a leading cause of vision loss, and steroids, the current treatment, have significant side effects.