Core Viewpoint - The company announced a significant milestone in the development of its candidate drug CBT-004, which is set to undergo a post-phase 2 meeting with the FDA on December 10, 2025, following the completion of its phase 2 clinical trial [1] Group 1: Clinical Trial Details - The company’s wholly-owned subsidiary, Cloudbreak USA, is conducting the phase 2 clinical trial for CBT-004, which began in December 2023 and is expected to be completed by May 2025 [1] - CBT-004 is a potential first-in-class ophthalmic drug that targets vascular endothelial growth factor receptors and platelet-derived growth factor receptors, aimed at treating vascularized eyelid lesions [1] - The results from the phase 2 trial indicate that CBT-004 is safe and well-tolerated among participants, achieving primary and several secondary endpoints in terms of efficacy [1] Group 2: Regulatory and Development Milestones - The upcoming post-phase 2 meeting with the FDA is crucial for discussing the potential development of a phase 3 clinical trial and the requirements for a new drug application [1]
拨康视云-B(02592.HK)：排定于12月10日与美国食品及药物管理局举行第2期临床试验后会议