Oculis Completes Enrollment in both DIAMOND Phase 3 Trials of OCS-01 in Diabetic Macular Edema

Core Viewpoint - Oculis Holding AG has completed enrollment in Phase 3 DIAMOND-1 and DIAMOND-2 trials for OCS-01 eye drops aimed at treating diabetic macular edema (DME), with pivotal data expected in Q2 2026, potentially leading to the first non-invasive topical treatment for DME [1][2][3] Company Overview - Oculis is a global biopharmaceutical company focused on innovative treatments for ophthalmic and neuro-ophthalmic diseases, with a pipeline that includes OCS-01 for DME, OCS-05 for acute optic neuritis, and OCS-02 for dry eye disease [12] Clinical Trials - The DIAMOND program consists of two Phase 3, double-masked, randomized trials evaluating the efficacy and safety of OCS-01 in over 800 patients, with a primary endpoint of change in best corrected visual acuity after 52 weeks [11][8] - Topline data from both trials is anticipated in the second quarter of 2026, followed by a New Drug Application (NDA) submission to the FDA [2][8] Product Details - OCS-01 is an OPTIREACH® formulation of high concentration dexamethasone eye drops, designed to provide a non-invasive treatment option for DME, contrasting with current invasive methods like intravitreal injections [7][9] - The product aims to improve drug solubility and increase residence time on the eye surface, facilitating treatment access in early disease stages [9] Market Need - DME is a leading cause of visual loss in diabetes, currently affecting approximately 37 million people globally, with projections to rise to 53 million by 2040, highlighting the urgent need for effective and less burdensome treatments [10]