Roche reports updated eye drug data and FDA filing acceptance, targets July 2027 decision

Roche Genentech has presented new data from its eye disease trials, a year after a mixed Phase 3 readout, and noted that the FDA has accepted its filing for vamikibart with a decision slated for July 2, 2027.

The Phase 3 Meerkat and Sandcat studies evaluated two doses of the IL-6 inhibitor vamikibart in patients with uveitic macular edema. While one trial met its primary endpoint and the other did not, the updated Week 52 analysis showed a higher proportion of patients achieving vision gains compared with sham treatment.

About two-thirds of patients did not need retreatment after Week 16, and those who did required only a single additional injection. Vision and macular edema measures remained improved, and safety continued to be favorable through Week 52.

Roche shared these results at the American Academy of Ophthalmology 2026 Annual Meeting, indicating that the data could support the upcoming FDA decision.