Core Viewpoint - The company has submitted a New Drug Application (NDA) for CBT-199, a potential best-in-class ophthalmic candidate, to the U.S. Food and Drug Administration (FDA) [1][2] Group 1: Product Development - CBT-199 is a novel topical ophthalmic emulsion designed to treat presbyopia, a common age-related condition where the eye's lens thickens and loses elasticity, leading to a decline in near vision [1] - The formulation utilizes the company's proprietary non-aqueous platform, containing a parasympathomimetic miotic agent that induces pupil constriction to create a pinhole effect, thereby increasing depth of focus and improving near vision [1] - The anhydrous formulation aims to prevent the degradation of active ingredients over time, enhancing drug stability, and features a consumer-friendly multi-dose bottle design with a long shelf life, providing a comfortable and soothing medication experience [1] Group 2: Clinical Trials and Regulatory Process - The drug discovery process for CBT-199 began in China in 2023, with preclinical animal studies assessing safety and tolerability starting in June 2023, which are expected to support future clinical trials [2] - The submission of the NDA marks the first step in the FDA's drug review process and obtaining regulatory approval to initiate clinical trials for CBT-199 [2]
拨康视云-B向美国药管局提交有关CBT-199的新药临床试验申请