Oculis: Phase 3 study with diabetic macular edema patients

Oculis S.A., (‘Oculis’) a global biopharmaceutical company purposefully driven to save sight and improve eye care, today announces the completion of enrollment for stage 1 of its Phase 3 DIAMOND (DIAbetic Macular edema patients ON a Drop) study evaluating the efficacy and safety of OCS-01 in patients with diabetic macular edema (DME).

At the end of 2021, Oculis launched its 2 stage Phase 3 DIAMOND study, a double-masked, randomized, vehicle-controlled, multi-center, multi-country study of OCS-01 in patients with DME. The primary endpoint of the trial, in both stages, is the mean change in the Best Corrected Visual Acuity “Early Treatment Diabetic Retinopathy Study” chart (BCVA ETDRS) from baseline to Week 6 (stage 1) and to Week 52 (stage 2). Several vision and anatomical secondary endpoints are also planned, including the mean change in macular thickness (CST, central subfield thickness) measured by SD-OCT (spectral domain optical coherence tomography) from baseline. More details can be found at www.clinicaltrials.gov – NCT05066997.

Leveraging Oculis’ proprietary Optireach technology, OCS-01 is a novel, high concentration, topical formulation of dexamethasone that has the potential to be the first topical eye drop and non-invasive treatment for DME. Oculis believes that OCS-01, if approved, could open up the possibility of treating DME patients via an eye drop, also offering prescribers the opportunity to provide customized treatment and maximize patient outcomes.

Riad Sherif, M.D., CEO of Oculis, said: "I am delighted Oculis has completed patient enrollment for stage 1 of our DIAMOND study. It is a huge testament to our dedicated team who are now focused on completing the treatment phase and preparing for stage 1 data readout which is expected in mid-2023. This study is a critical step in our effort to develop a novel and more easily accessible treatment for DME patients that can help prescribers improve patients’ eyesight and enhance their quality of life.”

David S. Boyer, M.D., Adjunct Clinical Professor of Ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles and Co-Primary Investigator for the DIAMOND study, said: “The ability to use a treatment with a topical route of administration would convey important advantages including an early and accessible treatment, greater convenience and less invasiveness. At present, OCS-01, developed using the proprietary Optireach technology, seems to be one of the most promising drug candidates in Phase 3. If approved, it could be used as a standalone treatment of early DME or as an adjunctive therapy. An efficacious topical therapy may allow physicians to treat DME earlier and/or potentially combine it with the current standard of care to drive more efficacy or durability.”

Arshad M. Khanani, M.D., M.A, Director of Clinical Research at Sierra Eye Associates and Clinical Associate Professor at University of Nevada, Reno School of Medicine, Reno, Nevada and Co-Primary Investigator for the DIAMOND study, commented: “If successful, OCS-01 will be an important therapeutic option in the treatment of patients with DME. As the first topical eye drop and non-invasive treatment for DME, OCS-01 can potentially benefit patients diagnosed with DME across the world to attain quicker and easier access to treatment. This may result in significantly reducing the burden to health care systems and improving patient outcomes.”

OCS-01 has been shown to improve visual acuity and reduce central macular thickness in DME patients compared to vehicle and demonstrated a promising safety profile in the 144-patient Phase 2b (DX-211) trial. The Phase 2 data were first presented at the Angiogenesis, Exudation, and Degeneration 2020 Conference in February 2020 and have since been published in the Acta Ophthalmologica journal in June 2022.