Benzinga | Mar 1, 2021 07:10AM EST

Ocular Therapeutix Announces First Patient Dosed in Phase 2 Clinical Trial of OTX-DED for the Short-Term Treatment of the Signs and Symptoms of Dry Eye Disease

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 patient in its Phase 2 clinical trial of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of the signs and symptoms of dry eye disease.

"We are excited to have recently begun dosing patients in the Phase 2 clinical trial of OTX-DED," said Michael Goldstein, MD, MBA, President, Ophthalmology and Chief Medical Officer. "Many dry eye patients experience episodic flares of their signs and symptoms related primarily to inflammation. Topical steroids are commonly used for the short-term treatment of dry eye but all of them contain preservatives that can lead to ocular surface toxicities such as itching and stinging and, when used more chronically, other adverse events such as elevated intraocular pressure or cataracts. OTX-DED is a new, investigational, physician-administered, preservative-free intracanalicular insert designed to deliver either 0.2 or 0.3 mg doses of dexamethasone that has the potential to provide effective treatment with fewer of those toxicities and adverse events. Along with OTX-CSI, our cyclosporin-containing intracanalicular insert, we now have two potentially transformative dry eye product candidates in Phase 2 development, one to chronically treat dry eye disease (OTX-CSI) and the other to acutely treat dry eye disease (OTX-DED), thereby effectively covering the broad spectrum of the approximately $5 billion global dry eye disease market."

The Phase 2 clinical trial is a U.S.-based, randomized, double-masked, vehicle-controlled, multi-center trial evaluating two different-strength formulations of OTX-DED (dexamethasone intracanalicular ophthalmic insert) in a total of approximately 150 subjects with dry eye disease. This trial is designed to assess the safety and efficacy of these two formulations of OTX-DED for the short-term treatment of signs and symptoms of dry eye disease by evaluating bulbar conjunctival hyperemia, corneal fluorescein staining eye dryness symptoms using visual analog scale (VAS), and other secondary endpoints in comparison with a matched vehicle control hydrogel insert.