Roche Unveils Phase III Data for Vamikibart in Uveitic Macular Edema
- Vamikibart, a non-steroid therapy, targets IL-6 to treat uveitic macular edema.
- Phase III trials MEERKAT and SANDCAT showed significant vision improvements.
- Vamikibart was well tolerated with low incidence of ocular adverse events.
- Trials involved doses of 0.25 mg and 1 mg compared to a sham procedure.
Introduction
Roche has announced results from two phase III studies, MEERKAT and SANDCAT, evaluating vamikibart for uveitic macular edema (UME), a condition causing vision loss due to fluid buildup in the macula.
Study Findings
Vamikibart, a non-steroid therapy targeting interleukin-6 (IL-6), showed significant vision improvements and reduced macular thickness in trials. The MEERKAT study achieved statistical significance, while SANDCAT showed nominal significance.
Safety and Tolerability
Vamikibart was generally well tolerated, with a low incidence of treatment-related ocular adverse events and no cases of retinal occlusive vasculitis. Common adverse events included conjunctival hemorrhage and raised intraocular pressure.
Trial Details
Both trials were global, multicentre, randomised, double-masked, and sham comparator-controlled, involving doses of 0.25 mg and 1 mg of vamikibart. Patients received treatment every four weeks for up to 16 weeks, with primary endpoints focusing on improvements in best corrected visual acuity (BCVA).
Source: Roche