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Zhaoke Ophthalmology Presented the Results of the Phase III Clinical Trial (COSMO) of CsA Ophthalmic Gel at ARVO 2022 Annual Meeting
2022-05-05


·        Premiere gathering for eye and vision scientists and those in affiliated fields to share the latest research findings and collaborate on innovative solutions.

·        This novel hydrogel cyclosporine formulation demonstrated clinically and statistically significant improvements in corneal and conjunctival staining.

·        Potentially revolutionize the treatment of dry eye by providing a highly effective, comfortable, once nightly dose of cyclosporine that will improve convenience as well as patient compliance


HONG KONG, 5 May, 2022 – Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology” or “the Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research and development, manufacturing and commercialization of treatments that address significant unmet medical needs, was selected by the Association for Research in Vision and Ophthalmology (“ARVO”) to present an abstract on the results of the Phase III clinical trial (“COSMO”) of CsA Ophthalmic Gel for the treatment of dry eye disease (“DED”) in the ARVO 2022 Annual Meeting in Denver, U.S..


ARVO is the largest and one of the most respected eye and vision research organizations in the world, with a mission to advance research worldwide into understanding the visual system and preventing, treating and curing its disorders. ARVO’s members include nearly 11,000 researchers from over 75 countries. The ARVO Annual Meeting is the premiere gathering for eye and vision scientists at all career stages, students, and those in affiliated fields to share the latest research findings and collaborate on innovative solutions. The theme of the 2022 Annual Meeting speaks to how great challenges in vision science can be overcome by collaboration and free sharing of ideas within interdisciplinary teams.


Dr. Parag A. Majmudar of Rush University Medical Center, Consultant of Zhaoke Ophthalmology and Prof. Zhou Shiyou of Zhongshan Ophthalmic Center, Sun Yat sen University presented an abstract on the results of the COSMO study of CsA Ophthalmic Gel in the meeting.


In the COSMO study, the mean (standard deviation (“SD”)) baseline inferior corneal staining scores (“ICSS”) was 3.0 (0.79), and the mean (SD) baseline Eye Dryness Score (“EDS”) was 65.8 (13.67). Compared to vehicle-treated patients, the CsA Ophthalmic Gel-treated patients showed statistically significant improvements in ICSS as early as Day 14 of treatment with continued and sustained improvements by Day 84. At the end of the treatment, 73.7% of CsA Ophthalmic Gel-treated patients showed a 1 point or greater improvement in ICSS versus 53.2% of patients on vehicle (p<0.0001). The mean change from baseline in EDS on Day 84 was 29.2mm (p<0.001) or 44.3% improvement in EDS over baseline. Treatment emergent adverse reaction was similar between CsA Ophthalmic Gel-treated and vehicle-treated patients with the most common side effect reported as eye pain reporting in 8.2% of all patients.


Dr. Majmudar and Prof. Zhou concluded by pointing out the clinically and statistically significant improvements in corneal and conjunctival staining, tear production and symptoms were observed in participants administrated with CsA gel 0.05% QN for treatment of moderate to severe DED CsA gel 0.05% QN will be a new efficacious, safe and well tolerated therapeutic option that might bring additional benefits of convenience and compliance as a once a day treatment for patients with moderate to severe dry eye. This novel hydrogel cyclosporine formulation promises to revolutionize the treatment of dry eye by providing a highly effective, comfortable, once nightly dose of cyclosporine that will improve convenience as well as patient compliance.


Dr. Parag A. Majmudar, Rush University Medical Center, Consultant of Zhaoke Ophthalmology, said, “We are honored to be selected as a presenter at the ARVO 2022. This prestigious event provided us with the opportunity to access a broad community of eye and vision scientists and enhance the visibility of our innovative asset, CsA Ophthalmic Gel, in the overseas market. We are pleased to share our insights and strong innovation capabilities and establish ourselves as an ophthalmology leader in China. We aim to bring CsA Ophthalmic Gel to the market as soon as possible and offer improved treatment to the DED patients in China and around the world.”


Prof. Zhou Shiyou, Zhongshan Ophthalmic Center, Sun Yat sen University, said, “It is my pleasure to work with Zhaoke Ophthalmology to present the results of the COSMO study. The results are encouraging, I am confident that CsA Ophthalmic Gel will be of great benefit to DED patients who are seeking a new treatment with improved level of comfort and convenience. This meeting also offered us a valuable opportunity to carry out in-depth academic exchange with ophthalmology experts around the world, and to access the frontiers of the industry development.”


About CsA Ophthalmic Gel

CsA Ophthalmic Gel is an innovative cyclosporine gel being developed by the Company in China for the treatment of 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.) had efficacy and safety profiles at least similar to those of Restasis® (0.05% CsA, b.i.d.). By eliminating the daytime administration and the associated discomfort and inconvenience, the Company’s CsA Ophthalmic Gel, administered once every night, is expected 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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Guangzhou Headquarters
Tel: 020-39062888
E-mail: info@zkoph.com
Add: No. 1 Meide 3rd Road, Pearl River Industrial Park, Nansha District, Guangzhou
Hong Kong Headquarters
Tel: (852)23145100
E-mail: info@zkoph.com
Add: Unit 716, 7/F, Building 12W Phase 3, Hong Kong Science Park Shatin, Hong Kong
Wechat