Oculis Finishes Enrollment for Phase 3 Trials of OCS-01 in Diabetic Macular Edema

Oculis Holding AG, a biopharmaceutical company specializing in ophthalmic and neuro-ophthalmic diseases, has successfully completed patient enrollment for its DIAMOND-1 and DIAMOND-2 Phase 3 trials. These trials, involving over 800 participants at 119 locations globally, are pivotal for assessing the efficacy and safety of OCS-01 eye drops in treating diabetic macular edema (DME). The completion of this enrollment marks a significant step toward the potential approval and broader market availability of OCS-01, especially as the first topical eye drop therapy for DME.

The DIAMOND (DIAbetic Macular edema patients ON a Drop) program is designed to provide a non-invasive treatment option for DME, aiming to transform current therapeutic approaches which primarily involve invasive procedures. OCS-01 is based on Oculis’ proprietary OPTIREACH® technology, which enhances drug solubility and retention on the eye surface, enabling effective delivery to the retina. This innovative formulation could offer a convenient alternative for early intervention in DME and possibly be combined with other treatments during advanced stages of the disease.

Riad Sherif, M.D., CEO of Oculis, emphasized the disciplined execution and commitment from all stakeholders, which has been pivotal in advancing the DIAMOND trials. He expressed gratitude to the investigators and medical community for their support and articulated optimism about the upcoming topline data expected in the second quarter of 2026. This data will be critical for the New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA).

Arshad M. Khanani, M.D., Steering Committee Chairperson for the DIAMOND Program, shared excitement regarding the rapid patient enrollment, highlighting the enthusiasm and recognition of OCS-01’s potential among investigators. The high enrollment reflects both the promising results from the initial phase of the DIAMOND trials and the strong interest from patients seeking a non-invasive DME treatment.

The trials are structured as double-masked, randomized, multi-center studies, where participants received either OCS-01 or a placebo. The primary endpoint of the trials is the change in visual acuity, measured by the best corrected visual acuity early treatment diabetic retinopathy study (BCVA ETDRS) letter score at the study's conclusion. Secondary endpoints include significant improvements in visual acuity and changes in the central subfield thickness of the retina.

DME, linked to high blood sugar levels typical in diabetes, presents considerable challenges due to its progressive nature and the limited treatment options currently available. It is a leading cause of vision impairment and blindness in diabetic patients, affecting millions globally. With the increasing prevalence of diabetes, experts anticipate a rise in DME cases, underscoring the critical need for effective and less burdensome treatments.

Oculis plans to provide further updates on the trials and its innovative pipeline at an upcoming R&D Day event. The company’s diverse clinical development portfolio also includes Privosegtor (OCS-05) for acute optic neuritis and Licaminlimab (OCS-02) for dry eye disease. Headquartered in Switzerland, Oculis operates in the U.S. and Iceland, driven by a mission to enhance eye care and preserve sight worldwide.