CLOUDBREAK-B Receives FDA Clearance for Safety Review of CBT-358 Investigational New Drug Application

Stock News07-17

CLOUDBREAK-B (ASX: 02592) has announced the completion of the review period concerning the Investigational New Drug (IND) application for CBT-358, which was submitted to the U.S. Food and Drug Administration on May 21, 2026. The FDA has finalized its safety assessment of the application and has raised no objections to the proposed clinical study.

As previously disclosed in the company's 2025 annual report dated March 31, 2026, and a subsequent voluntary business update announcement dated May 22, 2026, CBT-358 is the most recent addition to the product pipeline. It is a combination drug that integrates semifluorinated alkane (SFA+) with a TRPM8 (Transient Receptor Potential Melastatin 8) agonist, intended for the treatment of dry eye disease—a global market valued in the billions of dollars.

By combining these two components, CBT-358 is anticipated to address dry eye symptoms caused by insufficient tear production, aiming to enhance patient comfort. The company views the FDA's completion of the safety review for CBT-358 as a significant milestone in its clinical development program.

The group will continue to closely monitor the review progress and will issue further announcements as appropriate to keep its shareholders and potential investors informed about the latest developments in its business operations.

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