Zhaoke Ophthalmology-B (06622) announced that at the 7th National Dry Eye Academic Conference held in Shanghai, China on October 29, 2021, the company published the complete results of the key Phase III clinical trial (COSMO) of cyclosporine A eye gel (one of the company's main drug candidates) for the treatment of dry eye.
Multicenter, randomized, double-blind, placebo-controlled, efficacy and safety studies of cyclosporine A eye gel versus placebo in moderate to severe dry eye patients in China (COSMO study; clinicaltrials.gov registeration number: NCT04541888), the purpose is to evaluate the efficacy and safety of cyclosporine A eye gel in the treatment of patients with moderate to severe dry eye disease. The study involved 41 clinical trial centers, enrolling a total of 644 patients from December 2020, with recruitment completed two months ahead of schedule in mid-April 2021.
In the COSMO study, the mean subkeramental staining score (ICSS) baseline value (standard deviation) was 3.0 (0.79), while the dry eye score (EDS) baseline value mean (standard deviation) was 65.8 (13.67). Data showed significant improvement in ICSS earlier than on day 14 of treatment and continued to improve until day 84. At the end of treatment, 73.7% of patients treated with cyclosporine A eye gel showed 1 or more improvement in ICSS, compared with 53.2% of patients treated with placebo (p
Treatment with cyclosporine A eye gel was similar to the sudden adverse reactions that occurred during treatment in patients treated with placebo, with patients reporting eye pain, accounting for 8.2% of all patients.
Cyclosporine A Eye Gel is an innovative cyclosporine gel developed by the company in China for the treatment of dry eye. Unlike the Restasis emulsion formulation, cyclosporine A eye gel is a patented hydrogel whose patent rights have been approved internationally in China and internationally. This innovative formula enhances the pharmacokinetic efficacy and exposure of cyclosporine A on the ocular surface, giving cyclosporine A more time to inhibit dry eye. In fact, the results of previous Phase II studies have shown that the efficacy and safety characteristics of 0.05% cyclosporine A eye gel (once daily) are at least similar to those of Restasis (0.05% cyclosporine A twice daily). By eliminating all daytime medications and associated discomfort and inconvenience, the company's cyclosporine A eye gel, administered once a night, is expected to significantly improve patient compliance and quality of life. Recently, the company has appointed regulatory consultants for the potential development of cyclosporine A eye gel in North America.
Dry eye is a complex ocular surface disease caused by multiple factors and involving inflammation and various symptoms, and is one of the most common ophthalmic diseases in China and even in the world. According to China Insight Industry Consulting Co., Ltd., the market size of dry eye drugs in China is expected to grow from US$430 million in 2019 to US$6.7 billion in 2019, with a compound annual growth rate of 28.4%. The number of dry eye patients in China is expected to increase from 214 million in 2019 to 266 million in 2030, and the confirmed case rate is expected to rise from 11.5% in 2019 to 33.4% in 2030. At the same time, the number of dry eye patients in the United States is expected to increase from about 20 million in 2019 to about 28 million in 2030, and the confirmed case rate is expected to rise from 47.4% in 2019 to 65.2% in 2030.
![COSMOTUDE | Do "healing department work" old things reformer? Is it because there is no financial pressure?[fig]](data:image/gif;base64,R0lGODlhAQABAIAAAP///wAAACwAAAAAAQABAAACAkQBADs=)