Genentech presents new Phase 3 data for vamikibart

Genentech, a member of the Roche (RHHBY) Group, announced results from two Phase III studies evaluating the efficacy and safety of two doses of investigational vamikibart compared with a sham procedure that mimics intravitreal injections in people with uveitic macular edema. UME is characterized by the buildup 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 with vamikibart treatment. The data were presented at the American Academy of Ophthalmology annual meeting in Orlando, FL. In both trials, a numerically higher proportion of patients treated with vamikibart gained vision, with primary endpoint data demonstrating statistically significant superiority over sham in MEERKAT, though not in SANDCAT. Consistently across both trials, key secondary endpoints showed rapid and clinically meaningful improvements in average change from baseline in best corrected visual acuity, and average change from baseline in central subfield thickness, a key measure of macular edema, supporting the overall efficacy profile of vamikibart. The underlying variability of BCVA as an endpoint, along with variations in patient baseline characteristics and concomitant medications, may have influenced the differences in trial primary outcomes and further analyses are currently underway. Vamikibart was generally well tolerated in both studies, with a low incidence of treatment-related ocular adverse events and intraocular inflammation events, and no events of retinal occlusive vasculitis. The most common AEs in either trial in patients receiving vamikibart were conjunctival hemorrhage and raised intraocular pressure.