FDA To Hold End-of-Phase 2 Meeting With Cloudbreak On CBT-004 Ophthalmic Drug Candidate, 10 Dec 2025

(RTTNews) - Cloudbreak Therapeutics LLC, a wholly-owned subsidiary of Cloudbreak Pharma Inc., announced its intention to hold an End-of-Phase 2 meeting with the United States Food and Drug Administration (FDA) regarding CBT-004, one of its clinical-stage drug candidates. The meeting is expected to take place on 10 December 2025.

CBT-004 is a potential first-in-class ophthalmic drug, a multi-kinase inhibitor targeting vascular endothelial growth factor receptors and platelet-derived growth factor receptors, indicated for the treatment of vascularised pinguecula.

The Group commenced the Phase 2 clinical trial of CBT-004 in December 2023 and completed it in May 2025. The results demonstrated that CBT-004 was safe and well tolerated in subjects, meeting the primary endpoint as well as several secondary efficacy endpoints.

The Group finalized the clinical trial report in July 2025 and subsequently scheduled the End-of-Phase 2 meeting with the FDA. The Company considers this meeting a significant milestone in the development of CBT-004, as it will address potential Phase 3 clinical trial plans and New Drug Application requirements.

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