Zhaoke Ophthalmology Ltd. has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug $(IND.AU)$ application for its core product, Cyclosporine (CsA) Ophthalmic Gel. This gel is being developed for the treatment of moderate-to-severe dry eye disease and will advance to a Phase III, multicenter, randomized, double-masked, active-controlled study. The FDA's clearance allows Zhaoke to incorporate data from its completed pivotal Phase III clinical trial (COSMO study) and ongoing Phase III trial in China into its U.S. development plan. This regulatory milestone marks a significant step forward for Zhaoke in potentially improving patient compliance and quality of life with its innovative once-daily application gel.