- Oculis (OCS, Financial) has completed enrollment for Phase 3 DIAMOND trials evaluating OCS-01 eye drops in diabetic macular edema (DME).
- Over 800 patients enrolled across 119 sites worldwide, with topline data expected in Q2 2026.
- OCS-01 could become the first non-invasive topical treatment for DME, offering a new intervention for patients.
Oculis (OCS) announced the completion of patient enrollment for both Phase 3 DIAMOND trials of its OCS-01 eye drops, a potential breakthrough treatment for diabetic macular edema (DME). The trials, which are pivotal registration studies for global marketing applications, have enrolled over 800 patients from 119 sites, primarily located in the United States.
The DIAMOND program, consisting of two double-masked, randomized, multi-center trials, aims to evaluate the efficacy and safety of OCS-01 eye drops in DME patients over a treatment period of 52 weeks. The trials feature a 6-week induction phase followed by a 46-week maintenance phase. The primary endpoint is the change in best-corrected visual acuity (BCVA) at Week 52, alongside secondary endpoints such as percentage of patients with significant BCVA gain and change in central subfield thickness (CST).
Topline data from these Phase 3 trials are anticipated in the second quarter of 2026, with a New Drug Application (NDA) submission expected to follow. If approved, OCS-01 will be the first-ever non-invasive topical eye drop to treat DME, addressing a major unmet need for earlier intervention and providing an alternative for patients who respond inadequately to current anti-VEGF therapies.
Riad Sherif, M.D., CEO of Oculis, emphasized the company's commitment to advancing towards NDA submission and potential commercialization, highlighting the strong execution in trial enrollment. The DIAMOND steering committee, chaired by Arshad M. Khanani, M.D., expressed optimism about the ongoing progress and the potential transformative impact of OCS-01 in the treatment landscape for DME.
