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

Core Insights - Roche announced positive results from two phase III studies of vamikibart, an investigational treatment for uveitic macular edema (UME), showing potential for rapid vision improvement and reduction in macular thickness [1][2][7] Study Results - The studies, MEERKAT and SANDCAT, demonstrated statistically significant improvements in best corrected visual acuity (BCVA) in the MEERKAT trial, with a 36.9% improvement in the 1 mg vamikibart group compared to sham [5] - In the SANDCAT trial, a 20.7% improvement was observed in the 0.25 mg vamikibart group, although it did not reach statistical significance [5] - Key secondary endpoints showed rapid improvements in average change from baseline in BCVA and central subfield thickness (CST), supporting vamikibart's efficacy [2][5] Safety Profile - Vamikibart was generally well tolerated, with low incidence of treatment-related ocular adverse events and no cases of retinal occlusive vasculitis reported [4][9] - The most common adverse events included conjunctival hemorrhage and raised intraocular pressure [4] Treatment Context - UME is a significant cause of vision loss and blindness, particularly in working-age individuals, and current treatments with steroids have notable side effects [2][10] - Vamikibart represents a potential first-in-class non-steroid treatment option targeting interleukin-6 (IL-6), a key cytokine in UME's inflammatory pathway [11][12] Future Directions - Roche plans to discuss the study data with regulatory authorities globally, indicating a pathway towards potential approval and market introduction of vamikibart [2][7]