Cloudbreak Pharma Inc. has announced the successful completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) regarding the development of CBT-004 for the treatment of pinguecula. The company has reached alignment with the FDA on the Phase 3 study design, which will include primary efficacy endpoints previously achieved in the Phase 2 trial. Cloudbreak plans to assess efficacy at three months and safety at twelve months in the upcoming Phase 3 program, which is expected to begin in the first quarter of 2027 following the completion of remaining toxicity studies in 2026. Additionally, Phase 3 data from CBT-001, a potential treatment for pterygium, is anticipated in the fourth quarter of 2026. Results from the Phase 3 studies have not yet been presented.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Cloudbreak Pharma Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 9642967) on January 27, 2026, and is solely responsible for the information contained therein.