One year on from a mixed phase 3 readout, Roche has shared updated data from eye disease trials that could support FDA approval by July 2027.
The phase 3 studies tested two doses of the IL-6 inhibitor vamikibart in patients with uveitic macular edema (UME). Roche reported one hit and one miss on the trials’ primary endpoints, despite designing the studies to be identical. Since then, the Swiss drugmaker has continued to track patients who received intravitreal vamikibart injections while preparing filings for approval in markets including the U.S.
Roche used the American Academy of Ophthalmology 2026 Annual Meeting to share updated data from the Meerkat and Sandcat trials. At Week 52, a numerically higher proportion of patients achieved vision gains on vamikibart than on a sham treatment.
The company reported sustained improvements on a vision test and on a measure of macular edema. About two-thirds of eligible patients required no retreatment after Week 16, when Roche assessed its primary endpoints. Most patients who underwent retreatment only received one additional injection. Vamikibart maintained its favorable safety profile in the Week 52 analysis, Roche said.
Roche shared the update alongside news that the FDA has accepted a filing for approval of vamikibart for review, with a decision date of July 2027. Authorities in China, the European Union and Japan are also reviewing filings for approval of vamikibart.
The unmet need in UME could aid Roche’s case. Off-label therapies and ocular steroids form the backbone of UME treatment, exposing patients to long-term risks such as glaucoma and cataract formation. About 20% of UME patients progress to sustained blindness within three years of diagnosis.
Roche’s systemic IL-6 inhibitor, tocilizumab, is among the drugs given off-label to treat UME.
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