Ocular Therapeutix (NASDAQ:OCUL) dosed the first patients in its Phase 2 trial evaluating OTX-CSI for the treatment of dry eye disease.
The trial will enroll some 105 patients who will receive either one of two formulations of OTX-CSI, a cyclosporine intracanalicular insert, or vehicle insert. Patients will be followed for 16 weeks to assess the safety, tolerability and durability of OTX-CSI, in addition to its efficacy.
“OTX-CSI represents a novel route of delivering cyclosporine, a drug which has proven efficacy in the treatment of dry eye disease,” Dr. Michael Goldstein, Ocular Therapeutix’s CMO, said in a statement.
“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,” he added.