China-based Zhaoke Ophthalmology Ltd (HKG: 6622) announced that the New Drug Application (NDA) for its cyclosporine eye gel, a dry eye treatment candidate, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step toward bringing a new therapeutic option to patients suffering from dry eye syndrome.
Innovative Hydrogel Formula
Different from Restasis, the cyclosporine eye gel is a hydrogel under patent protection in China and beyond. This innovative formula enhances the pharmacokinetic efficacy and exposure level of cyclosporine on the ocular surface, providing more time for cyclosporine to inhibit dry eye syndrome. The enhanced formula is designed to improve treatment outcomes and patient satisfaction.
Clinical Trial Results
Results from the Phase III COSMO study demonstrated that cyclosporine eye gel could take effect as early as two weeks. Administered once a day, the gel is expected to significantly improve patient medication compliance and quality of life. This rapid onset of action and convenient dosing regimen position cyclosporine eye gel as a promising treatment option for dry eye syndrome.-Fineline Info & Tech
