Ocular Therapeutix, a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, 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,” said Michael Goldstein, MD, MBA, Chief Medical Officer. “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 U.S.-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 two weeks, the safety committee will meet prior to proceeding to a U.S.-based, randomized, masked, multi-center 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.

Dry eye is a common, multifactorial disease of the tears and ocular surface that results in symptoms of discomfort (such as burning sensation, itching, redness, stinging, pain and foreign body sensation), visual disturbance, and tear film instability that can cause potential damage to the ocular surface. Inflammation of the lacrimal gland and ocular surface have been shown to play a key role in dry eye disease, resulting in a reduction in tear production. Dry eye disease is one of the most common ophthalmic disorders presenting to clinicians and it is estimated that more than 19 million adults in the United States have been diagnosed with the disorder and an estimated 7 million classified as having a moderate to severe form of the disease.