Oculis completes enrollment in phase 3 DIAMOND trials for DME eye drop candidate

The DIAMOND-1 and DIAMOND-2 trials are investigating the company’s OCS-01 eye drops for the treatment of diabetic macular degeneration (DME). Image credit: AdobeStock/StockImageFactory

Oculis Holdings has completed enrollment in the phase 3 DIAMOND-1 (NCT05066997) and DIAMOND-2 (NCT06172257) trials. These trials are investigating the company’s OCS-01 eye drops for the treatment of diabetic macular edema (DME) and are designed as pivotal registration studies to support global marketing applications including NDA submission and approval by the US Food and Drug Administration (FDA). The trials have enrolled over 800 patients at 119 investigative sites throughout the United States as well as in several other countries around the globe.¹

The company notes that this milestone of the rapid completion of enrollment in the DIAMOND (DIAbetic Macular edema patients ON a Drop) program, consisting of 2 phase 3, double-masked, randomized, multicenter trials to evaluate the efficacy and safety of OCS-01 eye drops in patients with DME following 52 weeks of treatment, is an important step in the process of potentially bringing this candidate to market. Topline data from both phase 3 trials are expected in the second quarter of 2026, with NDA submission to follow thereafter.¹

Should the application be accepted by the FDA and 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.¹

In the company’s press release¹, Riad Sherif, MD, chief executive officer of Oculis, commented on the trials and the company’s next steps, saying, “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 toward 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.”

Arshad M. Khanani, MD, MA, FASRS, DIAMOND Program Steering Committee chairperson, Oculis Board of Directors member, Scientific Advisory Board chair of retina, and director of clinical research at Sierra Eye Associates, also spoke to the potential this treatment has for patients with DME. He said, “Together with my colleagues on the DIAMOND steering committee, I am greatly encouraged by the ongoing strong progress of OCS-01 and the phase 3 program. It’s exciting to witness the enthusiasm from the investigators due to the positive results seen in stage 1 of the DIAMOND program. The rapid enrollment of over 800 patients in both trials not only reflects the recognition among investigators of OCS-01’s significant potential as an effective, noninvasive therapy for DME, but also demonstrates the high level of patient interest in a topical eye drop treatment.”¹

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.

Reference:

1. Oculis completes enrollment in both DIAMOND phase 3 trials of OCS-01 in diabetic macular edema. Oculis Holdings AG. April 10, 2025. Accessed April 10, 2025. https://www.biospace.com/press-releases/oculis-completes-enrollment-in-both-diamond-phase-3-trials-of-ocs-01-in-diabetic-macular-edema