- DIAMOND is the first and only pivotal trial program ever conducted with a topical treatment for diabetic macular edema (DME)
- Over 800 patients randomized in DIAMOND-1 or DIAMOND-2 phase 3 trials at an industry-leading record speed across 119 sites worldwide primarily in the US; topline data readout expected in Q2 2026 with NDA submission to follow
- Company to provide an update on the DIAMOND program and its innovative late-stage pipeline at the upcoming in-person and virtual R&D Day on April 15
Oculis Holding AG (Nasdaq: OCS / ICX: OCS.IC) (“Oculis”), a global biopharmaceutical company focused on innovations addressing ophthalmic and neuro-ophthalmic diseases with significant unmet medical needs, announced that it has completed enrollment in both phase 3 DIAMOND-1 and DIAMOND-2 trials of OCS-01 eye drops in DME, designed as pivotal registration studies to support global marketing applications including NDA submission and approval by FDA.
The trials enrolled over 800 patients at 119 investigative sites throughout the United States and several other countries.
Rapid completion of enrollment in the DIAMOND (DIAbetic Macular edema patients ON a Drop) program, consisting of two (2) phase 3, double-masked, randomized, multi-center trials to evaluate the efficacy and safety of OCS-01 eye drops in patients with DME following 52-weeks of treatment, is an important milestone. Topline data from both phase 3 trials is expected in the second quarter of 2026, with NDA submission to follow thereafter.
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.
Riad Sherif, MD, CEO of Oculis, said: “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 non-invasive 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, commented: “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, non-invasive therapy for DME, but also demonstrates the high level of patient interest in a topical eye drop treatment.”
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 April 15. Register for the event here.
To learn more about the phase 3 DIAMOND trials, please visit diamondtrial.com.