English | 简体中文 | 繁體中文 | 한국어 | 日本語
Thursday, 31 October 2019, 11:10 HKT/SGT
Share:
COPFL announced that its wholly-owned subsidiary-ZKO, has successfully completed a Phase II trial of Cyclosporine A Ophthalmic Gel

China, Oct 31, 2019 - (ACN Newswire) - China Ophthalmology Focus Limited ("COPFL") today announced that its wholly-owned subsidiary, Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited ("ZKO"), has successfully completed a Phase II trial of Cyclosporine A (CsA) Ophthalmic Gel in China (clinicaltrials.gov registration No.:NCT03676335). Topline data show that the experimental drug has similar or a trend towards better efficacy than that of the marketed CsA Ophthalmic Emulsion.

The recently completed trial is a Phase II, randomised, single-blind, positive controlled, dose-finding study to assess the safety and efficacy of CsA Ophthalmic Gel in subjects with dry eye (Keratoconjunctivitis Sicca). The objective of the study is to explore and compare the efficacy and safety of CsA in a proprietary ophthalmic gel formulation with CsA Emulsion (formulation currently available on western markets) in the treatment of the above indication using different dosages and frequencies of administration, and to preliminarily determine the optimal conditions for the design of follow-up clinical study.

A total of 240 patients were enrolled in this study from 13 centers in China. The experimental drugs were given to three separate groups of subjects as follows: Treatment group A: CsA ophthalmic gel: 0.3 g: 0.15 mg, once daily; Treatment group B: CsA ophthalmic gel: 0.3 g: 0.15 mg, twice daily, with an interval of 12 hours; Treatment group C: CsA ophthalmic gel: 0.3 g: 0.3 mg, once daily. The positive control group received CsA Emulsion: 0.4 ml: 0.2 mg, twice daily, with an interval of 12 hours.

"Topline data of the current trial showed the new CsA Ophthalmic Gel formulation, (0.3 g: 0.15 mg, once daily) has similar or a trend towards better efficacy than the emulsion formulation currently on the western market," said Dr. Lit-Fui Lau, President of ZKO. "We believe that CsA Ophthalmic Gel is well positioned to address the unmet medical need in the treatment of patients with dry eye in China where ophthalmic CsA is still unavailable." "We have spent 10 years in the development of the patent-protected proprietary ophthalmic gel formulation of CsA. The topline data validated our commitment to the development of this innovative product," said Dr. Benjamin Li, Executive Director of COPFL.

ZKO plans to meet with the Center for Drug Evaluation in China to discuss and agree upon a Phase III protocol of the CsA Ophthalmic Gel trial. The pivotal study is expected to initiate patient recruitment in early 2020.

About Cyclosporine A Ophthalmic Gel

Cyclosporine A is a natural cyclic polypeptide immunosuppressant. It acts as a calcineurin inhibitor and suppresses T lymphocytes from releasing pro-inflammatory cytokines. The Cyclosporine A Ophthalmic Gel is a proprietary product shown to possess superior pharmacokinetics profile than that of the emulsion formulation in preclinical studies. It is under development for the treatment of keratoconjunctivitis sicca (dry eye) in China.

About China Ophthalmology Focus Ltd.

COPFL is an indirect non-wholly owned subsidiary of Lee's Pharmaceutical Holdings Limited (HKEx: 0950). Its Series A fund raising of USD 50 million in June 2019 was contributed by reputable investors including Coyote Investment Pte. Ltd., Panacea Venture Healthcare Fund I, L.P., Smart Rocket Ltd. and Vertex Profit International Ltd.. COPFL specializes in the development, manufacturing and marketing of ophthalmic drugs. It has built up a state-of-the-art development and production facility in Nansha, Guangzhou through its 100% subsidiary Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Limited. The facility supports the in-house development and future commercialisation of over 21 proprietary products and difficult to manufacture generics (ranged from pre-clinical to registration stage) for the Chinese and ASEAN markets. Its portfolio is diversified in having both small molecules and biologics, and having both novel and generic medicines, covering different ophthalmic indications from dry eye syndrome, glaucoma, wet Age-related Macular Degeneration (AMD), diabetic retinopathy to corneal and inflammatory diseases. It is currently the only modern facility in China that is recognised as being designed and built for ophthalmic drugs according to all applicable standards, namely China, Pharmaceutical Inspection Co-operation Scheme (PIC/S), EMEA, Japan and Food and Drug Administration (FDA).


Topic: Press release summary Sectors: Daily Finance, Healthcare & Pharm
https://www.acnnewswire.com
From the Asia Corporate News Network


Copyright © 2025 ACN Newswire. All rights reserved. A division of Asia Corporate News Network.

 

Latest Press Releases
GMG Commencing Sales of G(R) Lubricant and Advancing Regulatory Approvals  
July 9, 2025 09:00 HKT/SGT
"Development of Integrated Simulation Platform for Sustainable and Competitive Maritime Industry" has been selected as a R&D project under K Program  
Tuesday, July 8, 2025 7:30:00 PM
Eisai Selected as Supplier Engagement Leader, CDP's Highest Rating in the Supplier Engagement Assessment  
Tuesday, July 8, 2025 8:31:00 AM
Progress towards potassium-ion batteries  
July 8, 2025 06:48 HKT/SGT
Kincora Secures Strategic North American Investors and Announces Private Placement  
July 8, 2025 06:39 HKT/SGT
Small Businesses Embrace Social -- But Could be Missing a Trick in the Age of AI  
July 8, 2025 06:00 HKT/SGT
15 World Toppers and Near-Perfect Scorers for GIIS Singapore in IBDP 2025 Exams  
July 7, 2025 12:00 HKT/SGT
Huatai Foundation Supports NbS Summer School, Convening Global Youth to Tackle Ecological Conservation  
July 7, 2025 10:44 HKT/SGT
MHI Awarded Contract for Basic Design of Japan's Largest CO2 Capture Plant at Hokkaido Electric Power's Tomato-Atsuma Power Station  
Monday, July 7, 2025 10:15:00 AM
Fujitsu's high-precision skeleton recognition AI adopted to enhance figure skating athlete training  
Saturday, July 5, 2025 12:40:00 PM
More Press release >>
 Events:
More events >>
Copyright © 2025 ACN Newswire - Asia Corporate News Network
Home | About us | Services | Partners | Events | Login | Contact us | Cookies Policy | Privacy Policy | Disclaimer | Terms of Use | RSS
US: +1 214 890 4418 | China: +86 181 2376 3721 | Hong Kong: +852 8192 4922 | Singapore: +65 6549 7068 | Tokyo: +81 3 6859 8575