SOUTH SAN FRANCISCO (dpa-AFX) - Roche has announced encouraging results from two Phase III clinical trials evaluating the investigational drug vamikibart (0.25 mg and 1 mg doses) for the treatment of uveitic macular edema (UME). The studies compared vamikibart to a sham procedure mimicking intravitreal injections. Data from both trials suggest that vamikibart may offer rapid improvements in vision and reductions in macular thickness, a key indicator of retinal swelling.
In the MEERKAT trial, vamikibart demonstrated statistically significant superiority over sham in the primary endpoint, while the SANDCAT trial did not reach statistical significance. Nonetheless, both studies consistently showed clinically meaningful improvements in secondary endpoints, including best corrected visual acuity (BCVA) and central subfield thickness (CST), reinforcing the drug's potential efficacy. Variability in BCVA measurements and differences in patient baseline characteristics and concomitant medications may have contributed to the divergence in primary outcomes, and further analyses are ongoing.
Safety data revealed that vamikibart was generally well tolerated, with a low incidence of treatment-related ocular adverse events and intraocular inflammation. Importantly, no cases of retinal occlusive vasculitis were reported. The most common adverse events (?5%) among patients receiving vamikibart included conjunctival hemorrhage and elevated intraocular pressure.
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