Oculis Holding AG announced completion of the final patient visit in its phase 3 DIAMOND program evaluating OCS-01 eye drops for diabetic macular edema (DME). The program includes 2 randomized, double-masked, multicenter trials enrolling more than 800 patients. Topline results are expected in June 2026.

OCS-01 is a topical dexamethasone formulation designed to reach the posterior segment using the company’s delivery platform. The investigational therapy is intended as a noninvasive option for patients with DME, including those with early disease or suboptimal response to current treatments.

The DIAMOND trials evaluate efficacy and safety over 52 weeks. Patients were randomized to OCS-01 or vehicle, with a primary endpoint of change in best-corrected visual acuity. Secondary endpoints include the proportion of patients gaining at least 15 letters and change in central subfield thickness.

In a press release, Oculis said that positive results may support a regulatory submission to the US Food and Drug Administration (FDA) in the fourth quarter of 2026. RP