Zhaoke Ophthalmology Enrolls First Patient in Phase 3 Trial of Cyclosporine Ophthalmic Gel for Dry Eye Disease

Zhaoke Ophthalmology has announced the enrollment of the first patient in its Phase 3 clinical trial evaluating Cyclosporine (CsA) Ophthalmic Gel for the treatment of moderate to severe dry eye disease (DED). The trial marks a significant step forward for one of the company’s core pipeline assets.

Phase 3 Trial Design and Objectives

The ongoing Phase 3 study is a multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of CsA Ophthalmic Gel. The trial will be conducted across 25 clinical centers, enrolling a total of 360 patients with moderate to severe DED.

Overview of CsA Ophthalmic Gel for Dry Eye Disease

CsA Ophthalmic Gel is a proprietary hydrogel formulation of cyclosporine developed by Zhaoke in China. It has received patent approvals both domestically and internationally. The hydrogel base is engineered to enhance pharmacokinetics and ocular surface exposure, allowing cyclosporine more sustained contact with the eye, potentially increasing its therapeutic effect.

A previous Phase 2 trial demonstrated that once-daily application of 0.05% CsA Ophthalmic Gel at night showed comparable efficacy and safety to twice-daily Restasis (0.05% CsA). Furthermore, data from Zhaoke’s earlier Phase 3 COSMO study indicated that onset of action could occur within as little as two weeks of treatment initiation.

CEO Statement and Global Development Strategy

In a company statement, Li Xiaoyi (Benjamin), Chairman, Executive Director, and CEO of Zhaoke Ophthalmology, commented:

“CsA Ophthalmic Gel is one of Zhaoke’s core drug candidates and it is self-developed. The successful first patient recruitment indicates the initiation of the additional Phase III clinical trial of the drug, which would give us huge competitive advantage of out-licensing CsA Ophthalmic Gel to other parts of the world. While we continue to explore global opportunities for the drug, we are also preparing for the re-submission of the New Drug Application (NDA) for CsA Ophthalmic Gel in China.”

Regulatory Milestones and Trial Guidelines

In July 2024, Zhaoke received regulatory approval for a new Investigational New Drug (IND) application to initiate this additional Phase 3 study. The trial design adheres to the Technical Guidelines on Clinical Trials for Therapeutic Drugs for Dry Eyes, issued by China’s Center for Drug Evaluation (CDE) in September 2023.

This development aligns with Zhaoke’s strategy to expand its international licensing opportunities and strengthen its regulatory positioning in China as it prepares for NDA re-submission.