Oculis Holding (NASDAQ:OCS), a global biopharmaceutical company focused on ophthalmic breakthroughs, announced today the completion of the final patient visits in its DIAMOND Phase 3 clinical program.
The program, consisting of two identical registrational trials (DIAMOND-1 and DIAMOND-2), is evaluating the efficacy and safety of OCS-01 eye drops for the treatment of diabetic macular edema (DME).
The dual-trial program enrolled more than 800 patients globally, making it one of the largest clinical evaluations of a topical agent for a back-of-the-eye disease.
Both 52-week, randomized, double-masked trials were designed to confirm the promising results seen in Stage 1 of the DIAMOND program, which demonstrated significant gains in visual acuity and a rapid reduction in retinal thickness.
Current standard-of-care treatments for DME primarily involve frequent intravitreal injections of anti-VEGF agents.
OCS-01, a high-concentration topical formulation of dexamethasone utilizing Oculis’ proprietary Optireach® technology, aims to disrupt this market by offering a non-invasive, patient-administered alternative.
The Optireach technology is designed to enhance the solubility and residence time of the drug, allowing it to penetrate through the front of the eye to reach the retina.
The completion of the final patient visits keeps Oculis on a strict timeline for regulatory milestones.
The company expects to report topline results from the pooled Phase 3 data in June 2026.
If the data remains consistent with earlier clinical findings, Oculis plans to proceed with a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2026.
The commercial opportunity for OCS-01 is significant, as the U.S. DME market is currently estimated at approximately $3 billion.