Enrollment complete in phase 3 study of eye drop for diabetic macular edema
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Oculis has completed enrollment in the first stage of a phase 3 study evaluating a topical eye drop for the treatment of diabetic macular edema, according to a press release.
The DIAMOND study will assess the efficacy and safety of OCS-01, a high-concentration topical formulation of dexamethasone that could be the first noninvasive treatment for DME, the release said.
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The study’s primary endpoint is the mean change in best corrected visual acuity ETDRS letter score from baseline to week 6 (stage 1) and to week 52 (stage 2). Stage 1 of the study includes 148 randomly assigned participants, according to an Oculis spokesperson. The estimated total enrollment for both stages of the study is 482 participants, according to ClinicalTrials.gov.
The study will also explore other vision and anatomical changes, including mean change in macular thickness from baseline.
“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,” David S. Boyer, MD, co-primary study investigator, said in the release. “If approved, it could be used as a stand-alone 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.”
Oculis expects data readout for stage 1 in mid-2023.
Editor's note: On Jan. 9, 2023, this article was updated to more accurately reflect the number of study participants.
Reference:
- Multicenter study on the efficacy and safety of OCS-01 in subjects with diabetic macular edema. https://www.clinicaltrials.gov/ct2/show/NCT05066997. Updated Dec. 2, 2021. Accessed Jan. 5, 2023.
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