HONG KONG, 11 August, 2022 – 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 first patient was enrolled in the Phase II clinical trial of one of the Company’s drug candidates, ZKY001, for the indication of transepithelial photorefractive keratectomy (“TPRK”, surgical treatment for myopia), on 5 August 2022.

The Phase II clinical trial is a multi-center, randomized, double-blind and placebo-controlled study. The main objective of the trial is to evaluate the efficacy and safety of ZKY001 in the treatment of corneal epithelial defects after TPRK, and to determine the dosage of ZKY001 for the Phase III clinical trial. Led by Professor Zhou Xing Tao from the Eye and ENT Hospital of Fudan University, the trial will involve 12 centers and enroll a total of 120 patients.

Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, said, “ZKY001 is one of Zhaoke Ophthalmology’s self-developed innovative products. The first patient enrolled in the Phase II clinical trial of ZKY001 for TPRK marks another key step in the development of the treatment, as we have been exploring various indications for ZKY001 including pterygium and neurotrophic keratitis. This will lay a solid foundation for the Phase III clinical trial of ZKY001 in the near future. We aim to bring ZKY001 to market as soon as possible in order to offer a cornea repair treatment solution for patients suffering from corneal repair indications.” 

ABOUT ZKY001
ZKY001 is a seven-amino acid peptide derived from the functional fragment of Thymosin ß4 that binds actin, a type of protein that plays a central role in cell structure and movement. In addition to the Company’s leading Phase III innovative asset Cyclosporine A Ophthalmic Gel for dry eye, ZKY001 is another in-house developed program by the Company that is currently in a clinical stage.

ZKY001 has broad applications in corneal wound healing and can potentially be used in multiple corneal repair indications. In addition to the Phase II clinical study for corneal epithelium repair after endothelial keratoplasty, the Company is currently exploring three additional indications for ZKY001, including TPRK (surgical treatment for myopia), pterygium (an outgrowth in the cornea or conjunctiva) and neurotrophic keratitis (“NK”, a rare degenerative corneal disease).