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.
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