Lee’s Pharma Subsidiary Receives Green Light for Phase III Dry Eye Study and Completes Myopia Trial

Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a prominent Chinese pharmaceutical company, through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced significant advancements in its ophthalmic pipeline. The company’s cyclosporine A gel, intended for the treatment of dry eye, has received clearance to proceed to a Phase III clinical study in China for moderate to severe dry eye conditions. Concurrently, NVK002, an atropine external use eye solution for myopia progression, has concluded the final patient treatments in its Phase III clinical trial.

The cyclosporine A eye gel utilizes proprietary hydrogel technology, distinguishing itself from the emulsion formula of AbbVie’s Restasis. This innovation is expected to enhance the drug’s pharmacokinetics and ocular surface exposure. Positive results from a prior Phase II study demonstrated comparable efficacy and safety to Restasis, with the added benefit of once-nightly administration for patient convenience. The drug gained marketing approval in China in January of this year.

NVK002 is an investigational, preservative-free topical ophthalmic solution designed to control myopia progression in children and adolescents, with an anticipated shelf life exceeding 24 months. The China CHAMP study, which aimed to evaluate the efficacy and safety of NVK002 (0.01% and 0.02% low-dose atropine) in myopia progression among Chinese children and adolescents, enrolled 777 patients across 18 centers.- Flcube.com

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