The CLOUDBREAK-B(02592) successfully held a meeting after the second phase of the clinical trials for CBT-004.

CLOUDBREAK-B (02592) announced that on December 10, 2025, the company's wholly-owned subsidiary Cloudbreak USA successfully held a meeting with the U.S. Food and Drug Administration after the completion of Phase 2 of clinical trials. The meeting discussed the clinical development of CBT-004, a potential novel preservative-free eye drop for the treatment of vascularized lid fissures, a condition commonly found in individuals who are overexposed to ultraviolet radiation and the elderly. At the meeting after Phase 2 of clinical trials, the FDA provided feedback on the following matters: drug stability and specification studies, non-clinical studies needed to support the submission of a proposed new drug application to the FDA, and the design and endpoints of Phase 3 clinical trials for CBT-004. The FDA and Cloudbreak USA reached an agreement on the primary endpoint for approval of CBT-004, which is to reduce congestion symptoms, including their statistical and clinical significance, and to consider symptom relief as a potential shared primary endpoint. The meeting after Phase 2 of clinical trials was based on the results of the Phase 2 clinical trials completed in May 2025 and the clinical trial report completed in July 2025, which showed that CBT-004 was well tolerated and safe in participants and achieved the primary and several secondary efficacy endpoints. In particular, the results of the Phase 2 clinical trials showed that CBT-004 was effective in reducing conjunctival congestion, with effects observed as early as 7 days after the initial dose. Improvement in symptoms such as burning or stinging sensation, itching, and foreign body sensation was observed during the 28-day treatment period, and some symptom improvements were sustained significantly 4 weeks after discontinuation. Adverse events during treatment were mild and temporary and were not considered to be related to the study drug. The company believes that the successful meeting after Phase 2 of clinical trials marks a significant progress in the clinical development of CBT-004, particularly in advancing it to Phase 3 clinical trials, paving the way for the commercialization of CBT-004 after new drug application and approval.