Oculis Completes Enrollment in Both DIAMOND Phase 3 Trials of OCS-01 in DME

Oculis Holding said it has completed enrollment in both phase 3 DIAMOND-1 and DIAMOND-2 trials of OCS-01 eye drops in DME. The trials are designed as pivotal registration studies to support global marketing applications including NDA submission and approval by the FDA. The trials enrolled over 800 patients at 119 investigative sites throughout the US and several other countries.

Topline data from both phase 3 trials is expected in the second quarter of 2026, with NDA submission to follow. If approved, OCS-01 is expected to become the first topical eye drop for the treatment of DME and address unmet medical needs for early treatment intervention or for patients with inadequate response to anti-VEGF therapy.

“The completion of enrollment in both the DIAMOND-1 and DIAMOND-2 phase 3 trials shows strong focus on disciplined execution," Riad Sherif, MD, Chief Executive Officer of Oculis, said in a company news release. "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.”

An update on the progress of the phase 3 DIAMOND-1 and DIAMOND-2 trials will be included in Oculis’ upcoming in-person and virtual R&D Day on Tuesday April 15. Register for the event here.

To learn more about the Phase 3 DIAMOND trials, visit diamondtrial.com.