Ocular Therapeutix Announces First Patients Dosed in Phase 2 Clinical Trial of OTX-CSI for the Treatment of Dry Eye Disease

Ocular Therapeutix announced that it has dosed the first patients in its hase 2 clinical trial of OTX-CSI (cyclosporine intracanalicular insert) for the treatment of dry eye disease.

“Having successfully completed the phase 1 study, we are excited to have recently begun dosing patients in the phase 2 study of OTX-CSI,” Michael Goldstein, MD, MBA, Chief Medical Officer, said in a company news release. “OTX-CSI represents a novel route of delivering cyclosporine, a drug which has proven efficacy in the treatment of dry eye disease. 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. If successfully developed, we believe OTX-CSI has the potential to become a highly differentiated treatment that would provide significant benefit to patients with dry eye disease.”

The phase 2 clinical trial is a U.S.-based, randomized, masked, multicenter trial evaluating two different formulations of OTX-CSI with vehicle insert in approximately 105 subjects who will be followed for a period of 16 weeks. The enrollment of the phase 2 trial follows the successful completion of the U.S.-based, open-label, single-center phase 1 study evaluating the safety, tolerability and durability of OTX-CSI and assessing biological activity by measuring signs and symptoms of dry eye disease in five subjects over approximately 16 weeks. The phase 2 clinical trial is designed to further assess the safety, tolerability and durability and evaluate the efficacy of OTX-CSI in the treatment of dry eye disease.