Oculis Holding AG, a biopharmaceutical company focused on ophthalmic and neuro-ophthalmic diseases, announced today the completion of patient enrollment in its key Phase 3 Diamond-1 and DIAMOND-2 trials of OCS-01 eye drops for diabetic macular edema (DME). With over 800 patients enrolled at 119 investigative sites globally, the trials are designed to support global marketing applications, including a New Drug Application (NDA) submission to the US FDA.

The Diamond program (DIAbetic Macular edema patients ON a Drop) consists of two randomized, double-masked, multi-center trials to evaluate the safety and efficacy of OCS-01 following 52 weeks of treatment. Topline data from the trials is expected in the second quarter of next year (2026), with an NDA submission to follow.

Riad Sherif, medical director CEO of Oculis, said: “The completion of enrollment in both the Diamond-1 and Diamond-2 trials reflects our disciplined execution. We thank all stakeholders for their continued support in advancing this program towards NDA submission. We are focused on ensuring the program’s continued progress, which brings us closer to potentially offering the first non-invasive topical eye drop therapy for DME.”

Arshad Khanani, medical director, medical affairs, FASRS, chairperson of the Diamond program steering committee and director of clinical research at Sierra Eye Associates, added: “The rapid enrollment of over 800 patients in both trials highlights OCS-01’s potential as an effective, non-invasive therapy for DME and the significant interest from both investigators and patients in a topical eye drop treatment.”