Oculis Completes Patient Recruitment for Stage 1 of Phase 3 DIAMOND Study Evaluating the Efficacy and Safety of OCS-01 in DME
Oculis announced 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, multicenter, 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 noninvasive 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.
"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," Riad Sherif, MD, CEO of Oculis, said in a company news release. "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.”
“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," said David S. Boyer, MD, Adjunct Clinical Professor of Ophthalmology, Keck School of Medicine, University of Southern California, Los Angeles and Co-Primary Investigator for the DIAMOND study. "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.”
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.