Zhaoke in-house developed innovative eye drop formulation to treat corneal epithelial defects

Potential foundational therapy for a broad range of corneal epithelial diseases

HONG KONG, 26 January, 2021 – Zhaoke Ophthalmology Limited (“Zhaoke Ophthalmology” or “the Company”, SEHK: 6622), a leading ophthalmic pharmaceutical company dedicated to the research, development, manufacturing and commercialization of treatments that address significant unmet medical needs, is pleased to announce that the last patient was enrolled for the Phase II clinical trial of one of the Company’s core products, ZKY001, for the first indication it is exploring, Corneal Epithelial Defects (“CED”) on 21 January 2021.

The CED trial

The main objective of the CED trial is to evaluate the efficacy and safety of ZKY001 in the treatment of corneal epithelial defects and to assess the optimal dosage of ZKY001. The Phase II clinical trial for CED has enrolled 105 patients and is a multi-center, randomized, doublemasked, placebo-controlled study.

ZKY001 is a seven-amino acid peptide, LQ-7, that binds with actin, a type of protein that plays a central role in cell structure and movement. The treatment has broad applications in corneal wound healing and can potentially be used in multiple corneal repair cases.

Three additional indications

Zhaoke Ophthalmology is currently exploring three additional indications for ZKY001, including transepithelial photorefractive keratectomy (“TPRK”, surgical treatment for myopia), pterygium (an outgrowth in the cornea or conjunctiva) and neurotrophic keratitis (“NK”, a rare degenerative corneal disease).

The NK trial

In October 2021, Zhaoke Ophthalmology announced that the first patient was enrolled for the investigator-initiated trial (“IIT”) of ZKY001 for NK disease. The IIT is led by Professor Wu Huping from the Xiamen Eye Centre of Xiamen University and this trial plans to enroll a total of 40 patients by the second quarter of 2022.

TPRK and pterygium

The Company is also expecting the first patient enrolment for both Phase II clinical trials for two further indications of TPRK and pterygium shortly.

Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, “We are incredibly proud of our in-house developed treatments that have reached clinical trial stages, including Cyclosporine A Ophthalmic Gel for dry eye disease and ZKY001 for corneal epithelial diseases. At Zhaoke Ophthalmology, our focus is to bring to market first-in-class and best-in-class products to provide the best possible options for both patients and physicians. ZKY001 has broad applications in corneal wound healing and can potentially be used in multiple related indications. Apart from CED and NK, we also strongly believe in researching alternate applications for treatments and look forward to commencing Phase II clinical trials for ZKY001 for transepithelial photorefractive keratectomy and pterygium soon.”

Dr. Albert Tsai, Chief Medical Officer of Zhaoke Ophthalmology said, “We are excited about the progress of the trial despite the challenging situation with COVID-19, which made patient recruitment difficult. I am pleased by the professionalism and effort of our team to complete the patient enrolment and we look forward to continuing to deliver results and bring the best treatments to patients as early as possible.”