Core Viewpoint - Company Cloudbreak USA successfully held a Phase 2 clinical trial meeting with the FDA regarding CBT-004, a preservative-free eye drop intended for treating vascularized eyelid lesions, marking significant progress in its clinical development [1][2] Group 1: Clinical Trial Results - The Phase 2 clinical trial meeting was based on results completed in May 2025, showing that CBT-004 is safe and well-tolerated, achieving primary and several secondary efficacy endpoints [2] - CBT-004 demonstrated efficacy in reducing conjunctival hyperemia, with effects observable as early as 7 days after the first dose [2] - During the 28-day treatment period, improvements were noted in symptoms such as burning or stinging, itching, and foreign body sensation, with some effects persisting significantly for 4 weeks post-treatment [2] Group 2: FDA Feedback and Next Steps - The FDA provided feedback on drug stability, specifications research, and non-clinical studies required for the New Drug Application (NDA), as well as the design and endpoints for the Phase 3 clinical study [1] - A consensus was reached with the FDA to use the reduction of hyperemia symptoms as the primary endpoint for CBT-004's approval, with symptom relief as a potential co-primary endpoint [1][2] - The successful Phase 2 clinical trial meeting is seen as a major step towards advancing CBT-004 into Phase 3 clinical research, paving the way for its NDA and subsequent commercialization [2]
拨康视云-B(02592.HK)：成功举行第2期临床试验后会议