SOUTH SAN FRANCISCO (dpa-AFX) - Roche (RHHBY, RO.SW, ROG.SW) announced positive one-year results from its Phase III MEERKAT and SANDCAT studies evaluating investigational therapy vamikibart in adults with uveitic macular edema (UME), reinforcing the treatment's potential to improve vision and reduce retinal swelling over the long term.
The studies compared vamikibart with a sham procedure designed to mimic intravitreal eye injections. At 52 weeks, patients treated with vamikibart demonstrated sustained gains in vision and continued reductions in central subfield thickness, a key measure of swelling in the retina caused by fluid accumulation.
Across both trials, a greater proportion of patients receiving vamikibart achieved clinically meaningful vision improvements than those receiving sham treatment. The therapy also delivered durable benefits with a low treatment burden. Approximately two-thirds of eligible patients required no retreatment after 16 weeks, while most of those needing additional therapy received only one extra injection during the study period.
Roche said vamikibart maintained a favorable safety profile through one year of treatment, with low rates of treatment-related ocular adverse events and intraocular inflammation.
UME is the leading cause of moderate-to-severe vision loss among people with uveitis and primarily affects adults of working age. If approved, vamikibart could become the first non-steroid targeted therapy for the condition, potentially offering a new treatment option for patients who currently have limited alternatives.
Separately, Roche announced that the U.S. Food and Drug Administration has accepted the Biologics License Application for vamikibart for the treatment of UME. The regulatory submission is supported by data from the MEERKAT and SANDCAT studies, with an FDA decision expected by July 2027.
The company added that regulatory applications for vamikibart have also been accepted in the European Union, China and Japan.
Shares of Roche Holding closed at $54.09 on the OTCQX market on October 9, up $0.72, or 1.35%.
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