The Phase 2 clinical trial will evaluate two different formulations of OTX-CSI with vehicle insert, in around 105 subjects in the US


Ocular Therapeutix doses first patients with OTX-CSI in Phase 2 trial. (Credit: skeeze from Pixabay.)

Ocular Therapeutix has dosed first patients in a Phase 2 clinical trial of OTX-CSI, a cyclosporine intracanalicular insert, for the treatment of dry eye disease.

The Phase 2 clinical trial is a randomised, masked, multi-centre trial, designed to evaluate two different formulations of OTX-CSI with vehicle insert, in around 105 subjects in the US.

It aims to assess the safety, tolerability and efficacy of OTX-CSI in the treatment of dry eye disease, with subjects planned to be followed for 16 weeks, said the company.

Ocular Therapeutix chief medical officer Michael Goldstein said: “Having successfully completed the Phase 1 study, we are excited to have recently begun dosing patients in the Phase 2 study of OTX-CSI. OTX-CSI represents a novel route of delivering cyclosporine, a drug which has proven efficacy in the treatment of dry eye disease.”

Goldstein added: “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 OTX-CSI trial follows the completion of Phase 1 study

Patient enrolment in Phase 2 trial follows the completion of the Phase 1 study, an open-label, single-centre US-based study evaluating the safety, tolerability and durability of OTX-CSI.

The study also evaluated the biological activity by measuring signs and symptoms of dry eye disease in five subjects over a period of 16 weeks.

Dry eye disease is a common, multifactorial condition, resulting in symptoms of discomfort, including burning sensation, itching, redness, stinging, pain and foreign body sensation, along with visual disturbance, and instability in tear film that may cause damage to the ocular surface.

Inflammation of the lacrimal gland and ocular surface are believed to play important role in dry eye disease, resulting in a reduction in tear production.

Ocular Therapeutix is a biopharmaceutical company focused on the formulation, development, and commercialisation of therapies for eye diseases, by leveraging its bioresorbable hydrogel-based formulation technology