CLOUDBREAK-B (02592) announced that its wholly-owned subsidiary, ADS Therapeutics LLC, incorporated in Delaware, USA, has completed the review period for the Investigational New Drug (IND) application submitted to the U.S. Food and Drug Administration (FDA) on December 12, 2025, for CBT-199. CBT-199 is a potential best-in-class ophthalmic drug candidate developed by the group. The FDA has completed its safety review of the IND application and concluded that the company may proceed with the proposed clinical study. CBT-199 is a novel topical ophthalmic emulsion intended for the treatment of presbyopia, a common age-related condition where the eye's lens gradually thickens and loses elasticity, leading to a progressive decline in the ability to focus on nearby objects. The formulation utilizes the group's proprietary water-insoluble platform technology containing a parasympathomimetic miotic agent. It works by inducing pupil contraction to create a pinhole effect, thereby increasing the depth of focus and improving near vision. This anhydrous formulation is designed to prevent the decomposition of the active ingredient over time, enhancing drug stability. It is packaged in a consumer-friendly, self-preserving multi-dose bottle with an extended shelf life, aiming to provide a comfortable and soothing user experience. The company believes the FDA's completion of the safety review for CBT-199 represents a critical milestone in its clinical development. The group will continue to monitor the review progress closely and will issue further announcements to inform shareholders and potential investors of the latest developments in the group's business as appropriate.