CLOUDBREAK-B (02592) announced that on December 10, 2025, its wholly-owned subsidiary, Cloudbreak USA, successfully held a Phase 2 clinical trial post-meeting with the U.S. Food and Drug Administration (FDA). The meeting focused on the clinical development of CBT-004, a potential first-in-class preservative-free eye drop for treating vascularized pinguecula, a condition commonly seen in individuals with excessive UV exposure and the elderly.

During the meeting, the FDA provided feedback on several key aspects, including drug stability and specification studies, non-clinical studies required to support the proposed New Drug Application (NDA), as well as the design and endpoints for the Phase 3 clinical study of CBT-004. Notably, the FDA and Cloudbreak USA reached a consensus on using the reduction of conjunctival hyperemia as the primary endpoint for CBT-004 approval, considering its statistical and clinical significance, with symptom relief as a potential co-primary endpoint.

The Phase 2 post-meeting was based on the results of the Phase 2 clinical trial completed in May 2025 and the clinical trial report finalized in July 2025. The report demonstrated that CBT-004 was safe and well-tolerated in subjects, achieving both the primary efficacy endpoint and several secondary efficacy endpoints. Specifically, the Phase 2 results showed that CBT-004 was effective in reducing conjunctival hyperemia, with improvements observed as early as seven days after the first dose.

Additionally, symptom improvements—including burning or stinging sensations, itching, and foreign body sensation—were noted during the 28-day treatment period, with some effects remaining significant even four weeks after discontinuation. Adverse events during treatment were mild and transient, with none deemed related to the investigational drug.

The company believes that the successful completion of the Phase 2 post-meeting marks a significant milestone in the clinical development of CBT-004, particularly in advancing it to Phase 3 studies, paving the way for its NDA submission and future commercialization upon approval.