Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology”, “Zhaoke” or the “Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacture and commercialization of therapies that address significant unmet medical needs, is pleased to announce that the first patient was enrolled in the Phase III clinical trial of one of the Company’s flagship drug candidates, Cyclosporine (“CsA”) Ophthalmic Gel, for the treatment of moderate to severe dry eye disease (“DED”), on 3 April 2025.

The Phase III clinical trial is a multi-center, randomized, double-blinded and placebo-controlled study on the efficacy and safety of CsA Ophthalmic Gel in patients with moderate to severe dry eye. Led by Professor Zuguo Liu, Director of Eye Institute of Xiamen University, the trial will involve 25 centres and enrol a total of 360 patients.

In July 2024, Zhaoke Ophthalmology obtained regulatory approval for an Investigational New Drug (“IND”) application for an additional Phase III clinical trial of CsA Ophthalmic Gel. This Phase III clinical trial was designed based on the requirements outlined in the Technical Guidelines on Clinical Trials for Therapeutic Drugs for Dry Eyes issued by the Center for Drug Evaluation in September 2023.

Dr. Li Xiaoyi (Benjamin), Chairman of the Board, 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.”

About CsA Ophthalmic Gel

CsA Ophthalmic Gel is an innovative cyclosporine gel being developed by the Company in China for the treatment of moderate to severe DED. Unlike Restasis®, emulsion formulation, CsA Ophthalmic Gel is a proprietary hydrogel with patent approval in China and internationally. This novel formulation enhances the pharmacokinetic profiles and exposure of CsA on the ocular surface, giving CsA more time to exert its effect on DED.

In fact, the previous phase II study results suggested that 0.05% CsA Ophthalmic Gel (q.d.), applied once daily at night, had efficacy and safety profiles at least similar to those of Restasis® (0.05% CsA, b.i.d.) which is applied twice daily. This effectively eliminates the need for daytime administration and the associated discomfort and inconvenience. In addition, the results of the previous phase III study (COSMO) conducted by the Company indicate that the onset of action for CsA Ophthalmic Gel can start in as early as two weeks. As a result of once daily application and a rapid onset of action, the Company expects its CsA Ophthalmic Gel to significantly improve patients’ compliance and quality of life.

About Dry Eye Disease

DED is a complex multifactorial ocular surface disease involving inflammation and associated with different symptoms. It is one of the most common eye diseases in China and globally. According to China Insights Industry Consultancy Limited, the market size of DED drugs in China is forecasted to increase from US$430 million in 2019 to US$6.7 billion in 2030, at a compound annual growth rate of 28.4%. The number of DED patients in China is expected to grow from 214 million in 2019 to 266 million in 2030 with the diagnosis rate expected to increase from 11.5% in 2019 to 33.4% in 2030. Meanwhile, the number of DED patients in the United States is expected to grow from approximately 20 million in 2019 to approximately 28 million in 2030 with the diagnosis rate expected to increase from 47.4% in 2019 to 65.2% in 2030.

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