Oculis Completes Phase 3 Enrollment for OCS-01 in DME

Oculis Holding has announced the completion of patient enrollment in both DIAMOND-1 and DIAMOND-2, the two pivotal Phase 3 trials evaluating OCS-01 eye drops for the treatment of diabetic macular edema (DME). These trials are designed to support global regulatory submissions, including a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA).

Over 800 Patients Enrolled Across International Sites

The Phase 3 program enrolled more than 800 patients across 119 investigative sites in the United States and other countries. These trials aim to establish the safety and efficacy of OCS-01, a topical, noninvasive eye drop therapy, for patients with DME—a condition currently lacking approved topical treatments.

NDA Submission Planned Following 2026 Data Readout

Topline results from both DIAMOND trials are expected in the second quarter of 2026. If outcomes are positive, Oculis plans to submit an NDA shortly thereafter.

OCS-01 has the potential to become the first topical eye drop treatment for DME, offering a novel approach for early intervention or for patients who have an insufficient response to anti-VEGF therapy.

Company Statement on Trial Milestone

Riad Sherif, MD, Chief Executive Officer of Oculis, commented on the achievement:

“The completion of enrollment in both the DIAMOND-1 and DIAMOND-2 phase 3 trials shows strong focus on disciplined execution. I would like to thank all stakeholders participating in the trials and the whole medical community for their excellent support to advance this program towards NDA submission, which keeps us on track for a topline data readout from both studies in the second quarter of 2026. For the months to come, we will remain focused on execution to ensure the program's continued advancement, bringing us closer to potentially providing a transformational solution, with the first noninvasive topical eye drop therapy, for patients suffering from DME.”

Upcoming Update at R&D Day

Oculis will provide a progress update on the Phase 3 DIAMOND-1 and DIAMOND-2 trials during its upcoming R&D Day, which will take place both in-person and virtually on Tuesday, April 15.