Oculis: Enrollment for two Diabetic Macular Edema Phase 3 trials completed

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, today 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 the U.S. Food and Drug Administration (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, M.D., Chief Executive Officer 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, M.D., M.A, 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 Tuesday April 15. Register for the event here.

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

About Diabetic Macular Edema (DME)
DME is the leading cause of visual loss and legal blindness in patients with diabetes. Currently, it is estimated to affect around 37 million people worldwide and, with the rise of diabetes, the prevalence is expected to increase to 53 million by 2040 [1,2]. DME is an irreversible and progressive complication of diabetic retinopathy and is related to consistently having high blood sugar levels that damage nerves and blood vessels in the macula, the area of the retina responsible for sharp vision. DME occurs when blood vessels in the retina swell, and then leak, leading to a fluid build-up (edema) into the retina. There remains a significant need for safe, efficacious, and less burdensome treatments for DME patients.

About the Phase 3 DIAMOND Program of OCS-01 in Diabetic Macular Edema
The DIAMOND-1 (DIAbetic Macular edema patients ON a Drop) and DIAMOND-2 trials are Phase 3, double-masked, randomized, multi-center trials which will evaluate the efficacy and safety of OCS-01 eye drops in patients with DME. Oculis has enrolled over 800 patients across both pivotal trials who have been randomized 1:1 to receive OCS-01 or vehicle six times daily for the 6-week induction phase and then three times daily through week 52 for the maintenance phase. The primary endpoint is change in best corrected visual acuity early treatment diabetic retinopathy study (BCVA ETDRS) letter score at Week 52. Secondary endpoints include percentage of patients with ≥15-letter gain in BCVA and change in central subfield thickness (CST), both at Week 52. Both trials were initiated upon the positive findings from stage 1 of the DIAMOND program, which was announced in the second quarter of 2023.

References
[1] Yau et al. Global Prevalence and Major Risk Factors of Diabetic Retinopathy, Diabetes Care 2012 Mar; 35(3): 556-564
[2] International Diabetes Federation – diabetesatlas.org Estimated diabetes prevalence worldwide in 2021: 537m, reaching 783m in 2045