Roche has moved vamikibart into formal U.S. review, with the FDA accepting the filing for uveitic macular edema and setting a decision date of July 2027. The regulatory step matters because the phase 3 program arrived here with mixed top-line support: Roche previously reported one primary endpoint hit and one miss in two studies it had designed to be identical.
The company is now trying to strengthen the package with longer follow-up. At the American Academy of Ophthalmology 2026 Annual Meeting, Roche presented Week 52 data from the Meerkat and Sandcat trials, arguing that patients on intravitreal vamikibart injections maintained benefit beyond the Week 16 primary endpoint assessment.
The update Roche is using
Roche said that at Week 52 a numerically higher proportion of patients achieved vision gains on vamikibart than on sham treatment. The company also reported sustained improvements on a vision test and on a measure of macular edema.
The retreatment pattern is part of the commercial and regulatory argument. About two-thirds of eligible patients required no retreatment after Week 16, and most patients who did undergo retreatment received only one additional injection. Roche also said vamikibart maintained a favorable safety profile in the Week 52 analysis.
Because the source does not provide the underlying figures behind those claims, the immediate signal is less about magnitude than about whether longer-duration follow-up can make an uneven pivotal package more acceptable to regulators. Roche appears to be betting that durability, limited retreatment for many patients and a favorable safety read can help offset the earlier one-hit, one-miss result.
Why the filing may still be viable
Roche is not pursuing only the U.S. The company said authorities in China, the European Union and Japan are also reviewing filings for approval of vamikibart.
The unmet need in uveitic macular edema could help its case. According to the source, off-label therapies and ocular steroids are the backbone of treatment, exposing patients to long-term risks such as glaucoma and cataract formation, and about 20% of UME patients progress to sustained blindness within three years of diagnosis. Roche also already has a systemic IL-6 inhibitor, tocilizumab, used off-label in UME.
That leaves vamikibart as a regulatory test of whether a targeted ocular IL-6 approach can turn mixed pivotal data into an approvable product in a setting where current care remains imperfect.
