HONG KONG, 1 November, 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 the full results of the pivotal Phase III clinical trial (“COSMO”) of one of the Company’s core drug candidates, Cyclosporine A (“CsA”) Ophthalmic Gel for the treatment of dry eye disease (“DED”) at the 7th National Dry Eye Conference in Shanghai, China on October 29, 2021.
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) 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 with a total of 644 patients enrolled, the recruitment of which started in December 2020 and was completed two months ahead of schedule in mid-April 2021.
Analysis of the results of the COSMO study shows that the patient group who received CsA Ophthalmic Gel demonstrated statistically significant improvements, when compared to the patient group receiving the placebo treatment. 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). 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 in patients receiving CsA Ophthalmic Gel and the placebo treatment was similar, with eye pain as the most common side effect reported, in 8.2% of all patients.
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 and exposure of CsA on the ocular surface, giving CsA more time to act against DED. The previous Phase II study results suggested that 0.05% CsA had efficacy and safety profiles at least similar to those of existing emulsion formulation Restasis (0.05% CsA, b.i.d.). This means that unlike the current treatment, Zhaoke Ophthalmology’s CsA Ophthalmic Gel’s unique formulation requires only once a day application compared with 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 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. 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, “In China alone, there are over 200 million people who are suffering from DED. Our CsA Ophthalmic Gel is an innovative drug that has the potential to become the new standard of care for moderate-to-severe DED. The results of this pivotal trial mark a significant achievement for our Research & Development team who worked incredibly hard to complete the trial for this ahead of schedule. As one of our core drug candidates, we are looking forward to bringing CsA Ophthalmic Gel to market where it has the potential to be the world’s first single daily dose hydrogel, providing a welcome relief for the millions of people suffering from DED.”
Dr. Albert Tsai, Chief Medical Officer of Zhaoke Ophthalmology, said, “We are excited by the results of the Phase III trial of CsA Ophthalmic Gel, which showed statistically significant improvements in inferior corneal staining scores and an enhancement in Eye Dryness Score over baseline. This data shows the potential of this innovative cyclosporine gel to treat Dry Eye Disease. We believe that this drug will have a substantial impact on patients with DED, improving both their compliance and convenience.”
