OCUMENSION-B (01477) has announced that the first patient has been enrolled in the Chinese Phase III clinical trial for OT-202, its investigational therapy for dry eye disease (DED). This milestone signifies a crucial advancement for OT-202's development program in China and underscores the company's dedication to bringing innovative treatments to patients suffering from dry eye.

OT-202 is a first-in-class drug candidate designed for moderate-to-severe dry eye. It functions as a dual-target inhibitor, acting on both spleen tyrosine kinase (Syk) and vascular endothelial growth factor receptor 2. This mechanism is intended to produce a synergistic effect in treating dry eye by suppressing the inflammatory response.

The drug's Phase I trial, which was completed in February 2023, demonstrated a favorable safety and tolerability profile in healthy adult volunteers. The Phase II study, which commenced later that same month, was a randomized, double-blind, placebo-controlled trial designed to evaluate safety and efficacy. Enrollment for this phase concluded in November 2023, with a total of 213 patients recruited in China.

Results from the Phase II trial of OT-202 have been published in the leading international ophthalmology journal, Ophthalmology. In March 2024, OT-202 successfully met its primary endpoint in the Phase II study.