Zhaoke Ophthalmology Ltd (HKG: 6622), a former subsidiary of Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), has announced that its cyclosporine A eye gel for dry eye treatment has passed the market filing review and clinical trial on-site inspection by the National Medical Products Administration (NMPA). This milestone brings the firm’s drug closer to formal market approval.
Cyclosporine A Eye Gel: Innovation and Clinical Validation
Zhaoke’s cyclosporine A eye gel incorporates proprietary hydrogels, which differentiate it from the emulsion formula of AbbVie’s dry eye drug Restasis. This innovation allows for improved pharmacokinetics and enhanced drug exposure on the eye surface. A previous Phase II clinical study demonstrated that cyclosporine A eye gel (0.05%, once daily) is comparable in efficacy and safety to Restasis (0.05% cyclosporine A, twice daily). Additionally, the once-per-night administration of Zhaoke’s gel improves medication convenience for patients.
Regulatory Progress and Future Outlook
The New Drug Application (NDA) for Zhaoke’s cyclosporine A eye gel was accepted for review by the NMPA in June of last year. With the successful completion of the market filing review and clinical trial inspection, the drug is now in the final stages of obtaining formal market approval. This development positions Zhaoke to potentially offer a more convenient and effective treatment option for patients with dry eye disease.-Fineline Info & Tech
