Zhaoke Ophthalmology Ltd. Announces NMPA Acceptance of New Drug Application for CsA Ophthalmic Gel for Dry Eye Disease

Reuters
05-19
Zhaoke Ophthalmology Ltd. Announces NMPA Acceptance of New Drug Application for CsA Ophthalmic Gel for Dry Eye Disease

Zhaoke Ophthalmology Limited has announced that the National Medical Products Administration (NMPA) of China has accepted the New Drug Application (NDA) for its Cyclosporine (CsA) Ophthalmic Gel. This gel is being developed for the treatment of moderate to severe dry eye disease. The acceptance follows comprehensive communication and a pre-NDA discussion with the NMPA, along with a written endorsement based on results from the Phase III clinical trial, known as the COSMO study, and further data analysis. The CsA Ophthalmic Gel, which is designed for once-daily application, demonstrated a rapid onset of action within two weeks in the trial, potentially improving patient compliance and quality of life. Zhaoke Ophthalmology cautions that commercialization is not guaranteed, and advises cautious trading of its shares.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Zhaoke Ophthalmology Ltd. published the original content used to generate this news brief on May 19, 2025, and is solely responsible for the information contained therein.

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