Oculis begins phase 3 trial of new steroid for post-cataract surgery pain, inflammation
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Oculis has completed the first patient visit in its phase 3 OPTIMIZE-2 trial of OCS-01, the company’s preservative-free, once-daily topical formulation of dexamethasone for treating pain and inflammation after cataract surgery.
“Once daily OCS-01 could become an attractive option to treat pain and inflammation after ocular surgery with a highly potent anti-inflammatory effect,” Eric Donnenfeld, MD, clinical professor of ophthalmology at New York University and co-chair of Oculis Scientific Advisory Board, said in an Oculis press release. “This could be especially beneficial for high-risk patients, such as diabetic patients, who face an increased risk of complications following ocular surgery due to pre-existing underlying inflammation.”
Participants in this multicenter trial will be randomized to be treated post-cataract surgery with once daily OCS-01 or vehicle for 2 weeks, and researchers will examine anterior chamber cells and pain levels as primary endpoints.
Previous research from the OPTIMIZE-1 trial indicated that OCS-01 increased the amount of patients who were free of inflammation by day 15 and increased the amount of patients reporting zero pain at day 4 compared to vehicle.
“This timely progress also underscores the steadfast advancement of the OCS-01 development program thus far, as well as OCS-01’s potential as an eye drop treatment for both front- and back-of-the-eye diseases,” Riad Sherif, MD, Oculis CEO, said in the release. “We look forward to the important milestones expected in the year ahead, including four topline clinical readouts from OPTIMIZE-2 and the LEOPARD trials with OCS-01, the RELIEF trial with OCS-02 and from the ACUITY trial in Acute Optic Neuritis with OCS-05.”
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