Zhaoke Ophthalmology’s Phase III Clinical Trial of Cyclosporine A (CsA) Ophthalmic Gel for Dry Eye Disease Meets Primary Endpoint


    Largest Ever Completed Dry Eye Disease (DED) clinical trial to date in China
    Zhaoke Ophthalmology's in-house developed innovative drug candidate
    Targeting NDA Filing by the End of 2021
    Dry Eye Disease Affects Over 200 Million People in China
    Potential to become new standard of care for moderate-to-severe DED and a new blockbuster drug for China

    HONG KONG, Aug. 19, 2021 /PRNewswire/ -- 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 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 met its primary endpoint in inferior fluorescein corneal staining score (ICSS).

    Analysis of the results shows that the patient group who received CsA Ophthalmic Gel demonstrated statistically significant (P<0.0001) and clinically meaningful improvements, when compared to the patient group receiving the comparator treatment. Detailed results are expected to be announced at an upcoming medical meeting after the comprehensive statistical analysis is completed. Zhaoke Ophthalmology plans to submit a new drug application (NDA) to the National Medical Products Administration (NMPA) by the end of 2021, with the aim of commercializing the new treatment as early as 2023.

    CsA Ophthalmic Gel is an innovative cyclosporine 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 CsA more time to protect against DED. This means that unlike the current treatment, Zhaoke Ophthalmology's CsA Ophthalmic Gel's unique formulation requires only once a day application compared with the traditional twice a day usage.

    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 convenience.

    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 forecast 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. Chinese DED experts have agreed to recommend the use of CsA as an anti-inflammatory drug for the treatment of moderate-to-sever DED.

    Dr. Li Xiaoyi (Benjamin), Chairman and CEO of Zhaoke Ophthalmology, said, "Zhaoke Ophthalmology's CsA Ophthalmic Gel is an innovative drug that we have developed in-house, and is a huge accomplishment for our research and development team. DED affects more than 200 million people in China alone. We hope this pioneering treatment will become the new standard of care for moderate-to-severe DED in China. The development of a once-a-day CsA Ophthalmic Gel is significant as it is more comfortable and convenient to use than the current twice daily treatments and thus is expected to increase patient compliance. As China's first once-daily usage 0.05% CsA Ophthalmic Gel, we also look forward to taking this product to international markets, benefiting even more patients globally."

    Dr. Albert Tsai, Chief Medical Officer of Zhaoke Ophthalmology, said, "For the Phase III trial of CsA Ophthalmic Gel, we targeted an objective metric of drug efficacy in treating dry eye disease, which was to look for signs of improving corneal staining, in order to achieve the best possible results for these patients. This is a harder endpoint to achieve, versus a symptom improvement, which can be highly subjective and variable, and therefore does not always correlate directly with corneal health. This was the largest ever completed DED clinical trial to date in China and we are incredibly proud of how our dedicated team managed all aspects including rapid patient recruitment, low dropout rate and a primary endpoint achieved with high statistical significance."

    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 Ophthalmology 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. Topline results of the Phase III COSMO study show that its objective primary endpoint of inferior fluorescein corneal staining score (ICSS) has been met with statistical significance (p<0.0001). An NDA submission is expected by the end of 2021.

    About the Phase III Clinical Trial of CsA Ophthalmic Gel

    The Multi-center, Randomized, Double-Blind, Vehicle-controlled, Efficacy and Safety Study of Cyclosporine A Ophthalmic Gel Compared with Placebo in Subjects with Moderate to Severe Dry Eye Disease (COSMO Study; clinicaltrials.gov registration No.: NCT04541888) conducted in China aims to evaluate the efficacy and safety of CsA Ophthalmic Gel in patients with moderate-to-severe DED. It involved 41 clinical trial centers and enrolled a total of 644 patients, of which the recruitment started in December 2020 and completed two months ahead of schedule in mid-April, 2021. The last patient enrolled for the phase III clinical trial of CsA Ophthalmic Gel completed drug treatment on 12 July 2021.

    About Zhaoke Ophthalmology

    Founded in 2017, Zhaoke Ophthalmology (SEHK: 6622) is a leading ophthalmic pharmaceutical company dedicated to the research, development, manufacturing and commercialization of therapies that address significant unmet medical needs in China. The company was listed in the Main Board of the Hong Kong Stock Exchange on 29 April 2021.

    Zhaoke Ophthalmology has a comprehensive drug portfolio of 25 innovative and generic treatments covering five major eye diseases across both the front and back of the eye. Many of the drugs are being produced in its state-of-the-art and fully functional development and production facility in Nansha, Guangzhou.

    Through its ambitious growth strategy, including partnering with domestic and international pharmaceutical companies, Zhaoke Ophthalmology's goal is to become a leader in ophthalmology in China.

    Zhaoke Ophthalmology has received strong endorsement from blue-chip pre-IPO investors, including GIC, Hillhouse Capital, TPG, Loyal Valley Capital, OrbiMed, Aier Eye Hospital and FountainVest. The Company recently completed its HK IPO with cornerstone investors including CaaS Capital, GIC, Golden Valley, Jennison, Mass Ave, Matthews Asia, OrbiMed and VMS Investment.

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