Phase 2 trial of OTX-CSI for dry eye underway
The first patients have been dosed in a phase 2 clinical trial of OTX-CSI for the treatment of dry eye disease, according to a press release from Ocular Therapeutix.
The U.S.-based, randomized, masked, multicenter trial is investigating two formulations of OTX-CSI (cyclosporine intracanalicular insert) with vehicle insert in about 105 subjects who will be followed for 16 weeks. Safety, tolerability, durability and efficacy are under evaluation.
“Using our novel intracanalicular insert allows for preservative-free delivery of a consistent dose of cyclosporine that potentially makes OTX-CSI both less irritating to the ocular surface and faster acting than current standard of care drop therapies,” Michael Goldstein, MD, MBA, chief medical officer of Ocular Therapeutix, said in the release.
The trial follows the successful completion of a phase 1 study in five subjects over about 16 weeks.
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