Oculis Holding AG announces enrollment acceleration for Phase 3 DIAMOND trials for eye drops for DME

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Biopharmaceutical company Oculis Holding AG has announced the acceleration of patient enrollment for its 2 Phase 3 DIAbetic Macular edema patients ON a Drop (DIAMOND) trials, DIAMOND-1 and DIAMOND-2, of OCS-01 eye drops for diabetic macular edema (DME).¹ The eye drops, which utilize an OPTIREACH formulation of high concentration dexamethasone, are intended to be a non-invasive topical treatment, according to a news release.

“I am honored to chair the DIAMOND steering committee, comprised of leading experts from around the globe, as we support the outstanding team at Oculis in the late-stage development of OCS-01,” said Arshad M Khanani, MD, MA, FASRS, DIAMOND Program Steering Committee chairperson, Oculis Board of Directors member, Scientific Advisory Board Chair of Retina and director of Clinical Research at Sierra Eye Associates, in the release. “The results from Stage 1 of the DIAMOND Phase 3 program are promising, showing that patients treated with OCS-01 experienced significant improvements in visual acuity and a clinically meaningful reduction in macular edema. The DIAMOND program offers hope to the millions worldwide affected by DME, with OCS-01 potentially emerging as the first non-invasive topical eye drop therapy.”

The company has reported “substantial enrollment progress” since the end of this year’s second quarter through early October, stating that about 70% of patients are enrolled in the DIAMOND-1 trial, with about 40% of patients enrolled in the DIAMOND-2 trial. Both trials in the DIAMOND program are double-masked, randomized, and multi-centered and will evaluate the efficacy and safety of OCS-01 eye drops in patients with DME.¹

To aid in the development of OCS-01, Oculis also announced the expansion of its DIAMOND program committees with globally renowned retina experts on board. The committees are now comprised with 20 medical professionals, according to Oculis.¹

“We are very pleased with the strong momentum in patient enrollment in DIAMOND-1 and DIAMOND-2 Phase 3 trials which continues to exceed our expectations,” said Riad Sherif, MD, Oculis CEO, in the release. “We are also honored to have such a distinguished and broad group of global experts on the expanded DIAMOND program committees and look forward to working with the committees and benefiting from their deep expertise as we advance the DIAMOND program.”

Reference:

1. Oculis accelerates enrollment in both DIAMOND Phase 3 trials of OCS-01 in diabetic macular edema and expands its DIAMOND program committees. News release. Oculis Holding AG. October 21, 2024. Accessed October 21, 2024. https://investors.oculis.com/news-releases/news-release-details/oculis-accelerates-enrollment-both-diamond-phase-3-trials-ocs-0