OCS-01 eye drop for DME in second stage of phase 3 trial
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PARK CITY, Utah — Stage one of the phase 3 DIAMOND trial of OCS-01, a high-concentration dexamethasone eye drop for diabetic macular edema, showed promising safety and efficacy outcomes. Stage two of the trial is underway.
“OCS-01 has a really exciting potential to fill that glaring, almost unspoken treatment gap in retina — the noninvasive approach,” Courtney Crawford, MD, said at Clinical Trials at the Summit.
DIAMOND is a multicenter trial conducted at 39 U.S. and European sites. One hundred forty-eight patients were randomly assigned 2:1 to receive OCS-01 (Oculis) or vehicle, six drops per day in the first 6 weeks and three drops per day during the following 6-week maintenance phase.
At 6 weeks, a mean gain of more than seven letters was achieved in the OCS-01 group and maintained throughout the duration of the study. More than 25% of the patients gained at least three lines, which was maintained throughout the study. A 60 µm reduction in central retinal thickness was achieved at 2 weeks and was also maintained for the duration of the study.
Both phakic and pseudophakic patients had almost identical visual gains, and there was no cataract development at 12 weeks. A predictable 15% IOP increase was reported, but there were no unexpected adverse events.
Crawford showed the case of one patient in the study, courtesy of David Boyer, MD, who had best corrected visual acuity of 57 letters at baseline and central retinal thickness of 479 µm.
“At the conclusion of the study, [the patient had] 71 letters, a nice foveal contour and 256 µm. So that’s an outstanding result,” he said.
Stage two of the DIAMOND trial began in December 2023. Four hundred patients will be included and followed over 52 weeks.
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Crawford C. Update on OCS-01: A novel topical drop for DME in phase 3 trials. Presented at: Clinical Trials at the Summit; June 8, 2024; Park City, Utah.
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