CLOUDBREAK-B (02592) announced that on December 15, 2025, its wholly-owned subsidiary, ADS Therapeutics LLC, submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for CBT-199, a potential best-in-class ophthalmic drug candidate developed by the group.
CBT-199 is a novel topical ocular emulsion designed to treat presbyopia, a common age-related condition characterized by the thickening and loss of elasticity in the eye's crystalline lens, leading to progressive difficulty in focusing on near objects.
The drug utilizes the group's proprietary water-insoluble platform formulation, containing a parasympathomimetic miotic agent. It works by inducing pupil constriction to create a pinhole effect, thereby increasing depth of focus and improving near vision.
The anhydrous formulation is designed to prevent active ingredient degradation over time, enhancing drug stability. It features a consumer-friendly, self-preserving multi-dose bottle design with an extended shelf life, offering a comfortable and soothing user experience.
As disclosed in the company's prospectus dated June 24, 2025, the group initiated the drug discovery process for CBT-199 in China in 2023. Since June 2023, CBT-199 has undergone preclinical animal studies evaluating its safety and tolerability, with results expected to support future clinical trials.
The IND submission marks the first step in the FDA's drug review process and is essential for obtaining regulatory approval to commence clinical trials for CBT-199.
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