Benzinga | Sep 29, 2020 08:07AM EDT

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

BEDFORD, Mass.--(BUSINESS WIRE)-- Ocular Therapeutix(tm), Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has dosed the first patients in its Phase 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," said Michael Goldstein, MD, MBA, Chief Medical Officer. "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, multi-center 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.