Zhaoke enrolls first patient in phase 3 trial of cyclosporine ophthalmic gel for dry eye

(Image Credit: AdobeStock/Pattarisara)

Zhaoke Ophthalmology Limited has enrolled the first patient in its phase 3 clinical trial of cyclosporine A (CsA) ophthalmic gel, for the treatment of moderate to severe dry eye disease (DED).¹

The phase 3 clinical trial is a multicenter, randomized, double-blinded, and placebo-controlled study on the efficacy and safety of CsA ophthalmic gel. The trial will involve 25 centers and enroll 360 patients.

CsA ophthalmic gel is an innovative cyclosporine gel being developed by Zhaoke in China for the treatment of moderate to severe DED. The proprietary hydrogel has patent approval in China and internationally and “enhances the pharmacokinetic profiles and exposure of CsA on the ocular surface, giving CsA more time to exert its effect on DED.”

Data from a previous phase 2 study suggested that 0.05% CsA ophthalmic gel, applied once daily at night, had efficacy and safety profiles at least similar to those of Restasis (0.05% CsA) applied twice daily. Additionally, results of the previous phase 3 study (COSMO) conducted by Zhaoke indicate that the onset of action for CsA ophthalmic gel can occur as early as 2 weeks after application.

Li Xiaoyi (Benjamin), chairman of the board, executive director, and CEO of Zhaoke Ophthalmology, commented on the trial results in a release from the company.

“CsA ophthalmic gel is one of Zhaoke’s core drug candidates, and it is self-developed. The successful first patient recruitment indicates the initiation of the additional phase 3 clinical trial of the drug, which would give us [a] huge competitive advantage of out-licensing CsA ophthalmic gel to other parts of the world. While we continue to explore global opportunities for the drug, we are also preparing for the resubmission of the new drug application (“NDA”) for CsA ophthalmic gel in China,” said Xiaoyi.

In July 2024, Zhaoke Ophthalmology obtained regulatory approval for an investigational new drug application for an additional phase 3 clinical trial of CsA ophthalmic gel. According to the company, this clinical trial was designed based on the requirements outlined in the Technical Guidelines on Clinical Trials for Therapeutic Drugs for Dry Eyes issued by the Center for Drug Evaluation and Research in September 2023.

Reference

1. Zhaoke Ophthalmology enrols the first patient for the additional phase III clinical trial of the self-developed innovative drug CsA ophthalmic gel. Zhaoke Ophthalmology Limited. April 17, 2025. Accessed April 17, 2025. https://www.zkoph.com/news?lang=en&sid=107