Ocular Therapeutix announced that it has dosed the first patients in its phase 1 clinical trial of OTX-CSI (cyclosporine intracanalicular insert) for the treatment of dry eye disease (DED).
“We are pleased to be advancing OTX-CSI in the chronic treatment of dry eye disease,” Michael Goldstein, MD, MBA, Chief Medical Officer, said in a company news release. “We believe that the intracanalicular route of administration could provide key benefits in all ocular surface diseases but particularly in dry eye. The intracanalicular route allows for preservative-free delivery of a constant dose of cyclosporine, so it may be less irritating to the ocular surface than drop therapies. Also, blocking the punctum is a common treatment for DED itself and can provide immediate relief of symptoms. By being less-irritating and faster-acting than current therapies, we believe OTX-CSI has the potential to become a highly differentiated treatment that, if successfully developed, would significantly increase patient satisfaction.”
The phase 1 clinical trial is a US-based, open label, single center trial that intends to enroll 5 subjects and follow them for approximately 4 months. The study will evaluate safety and tolerability of OTX-CSI and assess biological activity by measuring signs and symptoms of DED over this time period. OTX-CSI is administered by a physician as a bioresorbable intracanalicular insert and is designed to release drug to the ocular surface for up to 3 months. After all subjects in the phase 1 trial have been followed for at least 2 weeks, the safety committee will meet prior to proceeding to a U.S.-based, randomized, masked, multicenter phase 2 clinical trial evaluating two different formulations of OTX-CSI with vehicle insert in approximately 105 subjects. The company anticipates initiating the phase 2 clinical trial in the fourth quarter of 2020.