Zhaoke Ophthalmology Limited announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s investigational new frug (IND) application for cyclosporine (CsA) ophthalmic gel, one of the company’s core products, for the treatment of moderate-to-severe dry eye disease (DED) .
The upcoming study is set to be a phase 3, multicenter, randomized, double-masked, active-controlled study.
Based on comprehensive scientific communication and discussions with the FDA, Zhaoke has aligned with the FDA to incorporate data from the completed pivotal phase 3 clinical trial (COSMO study) as well as the ongoing phase 3 trial in China into its U.S. development plan.
Meanwhile, a new drug application (NDA) for CsA Ophthalmic Gel was accepted by the National Medical Products Administration (NMPA) of China in early May 2025.
Dr. Li Xiaoyi (Benjamin), Chairman of the Board, Executive Director and CEO of Zhaoke Ophthalmology, commented, “This marks a pivotal moment for our Company as we celebrate the FDA’s IND clearance for our self-developed CsA Ophthalmic Gel - a testament to years of innovation and dedication. This milestone accelerates our mission to deliver transformative therapies to patients in need and underscores our R&D capabilities on a global stage. With this clearance, we take a big step toward clinical trials and, ultimately, bringing this breakthrough treatments to the North American market. We remain committed to pushing boundaries in eye care and improving lives worldwide through cutting-edge science.”
About CsA Ophthalmic Gel
CsA Ophthalmic Gel is an innovative cyclosporine gel developed by the company in China to treat moderate to severe dry eye disease (“DED”). Unlike Restasis®, emulsion formulation, CsA Ophthalmic Gel 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 exert its effect on DED.
The previous phase 2 study results suggested that 0.05% CsA Ophthalmic Gel (q.d.), applied once daily at night, had efficacy and safety profiles at least like those of Restasis (0.05% CsA, BID), which is used twice daily. This eliminates the need for daytime administration and the associated discomfort and inconvenience. In addition, the results of the previous phase III study (COSMO) conducted by the Company indicate that the onset of action for CsA Ophthalmic Gel can start in as early as two weeks. As a result of once-daily application and a rapid onset of action, the Company expects its CsA Ophthalmic Gel to improve patients’ compliance and quality of life significantly.