• Proprietary hydrogel formula with patent approval in China and internationally 

• China first single daily dosing, compared to current treatment with twice daily dosing 

HONG KONG, 13 July, 2021 – Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology”, SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research, development and commercialization of therapies that address significant unmet medical needs, is pleased to announce that the last patient enrolled for the phase III clinical trial of one of the Company’s core drug candidates, Cyclosporine A (“CsA”) Ophthalmic Gel for the treatment of dry eye disease (“DED”), has completed drug treatment on 12 July 2021. 

CsA Ophthalmic Gel is an innovative drugcyclosporine gel being developed by Zhaoke Ophthalmology in China for the treatment of DED. It is a proprietary hydrogel with patent approval in China and internationally. This novel formulation enhances the pharmacokinetic profiles of CsA on the ocular surface allowing similar efficacy to that of the Cyclosporine A products currently available for DED. However, unlike the current treatment, Zhaoke Ophthalmology’s CsA Ophthalmic Gel’s unique formulation stays on the ocular surface for longer, requiring only once a day dosing compared with traditional twice daily dosing. 

By eliminating the daytime administration and associated discomfort and inconvenience, Zhaoke Ophthalmology’s CsA Ophthalmic Gel, which is administered once every night, is expected to significantly improve patients’ compliance and quality of life. 

The Phase III clinical trial conducted in China aims to evaluate efficacy and safety of CsA Ophthalmic Gel in patients with moderate-to-severe DED, involving 41 clinical trial centers and has enrolled a total of 644 patients. Recruitment started in December 2020 and was completed in mid-April 2021, ahead of schedule. The patient dropout rate for this trial is approximately 7%, demonstrating a positive study compliance. In addition, data indicates the safety profile meets expectation. Results regarding efficacy and safety will be disclosed upon completion of analysis in a few months’ time. Zhaoke Ophthalmology plans to submit a new drug application to the National Medical Products Administration around the end of 2021 with an aim to commercialize the new treatment as early as 2023. 

DED is one of the most prevalent eye diseases in China and globally. According to China Insights Consultancy, the market size of DED drugs in China is forecasted to increase from US$430.1 million in 2019 to US $6.7 billion in 2030, at a compound annual growth rate of 28.4%. DED is a complex multifactorial ocular surface disease involving inflammation and associated with different symptoms. Moderate-to-severe cases are typically treated with anti-inflammatory drugs.

Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, “Dry Eye Disease affects more than 200 million people in China alone. There is clearly a significant unmet need to treat patients suffering from this disease. At Zhaoke Ophthalmology we are developing the world’s first single daily dose hydrogel, CsA Ophthalmic Gel, which eliminates daytime administration and the associated discomfort and inconvenience, and aims to dramatically improve patient compliance and quality of life. The rapid patient recruitment and completion of our clinical phase III trial as well as the low patient dropout rate speak to the execution capabilities of our clinical and R&D teams. In addition to serving our core Chinese market, we intend to introduce this in-house developed innovative product to other countries and markets at a later stage.”

About Cyclosporine A (CsA) Ophthalmic Gel

CsA is a natural cyclic polypeptide immunosuppressant. It acts as a calcineurin inhibitor and suppresses T lymphocytes from releasing pro-inflammatory cytokines. The CsA Ophthalmic Gel developed by Zhaoke is a proprietary product shown to possess a pharmacokinetics profile superior to that of the emulsion formulation (Restasis) in preclinical studies. In a Phase II head-to-head comparative trial, CsA Ophthalmic Gel displayed efficacy and safety profile at least similar to those of Restasis (b.i.d.) with only once a day dosing. It is currently under Phase III development for the treatment of moderate-to-severe DED in China.