Cloudbreak Pharma Inc. (2592.HK), a clinical-stage biopharmaceutical company, announced on Thursday that its final patient from the phase 3 trial for CBT-001 had completed their 12-month endpoint visit for pterygium.
Pterygium is a triangular fibrovascular growth located on the cornea that connects to the conjunctiva. It results from excessive UV exposure and is marked by symptoms such as redness and a sensation of having a foreign body in the eye. If left untreated, it can lead to serious vision problems.
The company estimates pterygium impacts under one billion people, of whom 15 million are from the U.S. The patients are treated for their symptoms, as there is currently no FDA-approved treatment for pterygium.
CBT-001 is a novel multi-kinase inhibitor (MKI) developed as an eye drop for the treatment of pterygium. It aims to target the underlying angiogenic and fibrogenic factors that contribute to the disease.
Currently in a phase 3 trial, CBT-001 has the potential, if approved, to be the first pharmacologic treatment that eliminates the need for surgery and addresses the unmet medical needs associated with pterygium.
The phase 3 trial is a multicenter, double-masked, randomized, vehicle-controlled study.
According to the company, the phase 3 trial enrollment began in June 2022 in the U.S. and expanded across China, Australia, and India by July 2024. The enrollment was completed in May 2025, enrolling a total of 660 patients.
The trial evaluated two doses of CBT-001 emulsion that were administered twice daily over a period of 24 months. The primary endpoint was to reduce conjunctival hyperemia caused by a vascularized lesion and prevent the progression of pterygium.
Cloudbreak reported that the 12-month primary endpoint demonstrated a reduction in lesion size and ocular symptoms in its phase 3 trial for CBT-001. The company anticipates that the top-line efficacy data for the 12-month period will be available in the third quarter of 2026. If these results are positive, they may support the company's commercial filings.
Abu Abraham, Chief Medical Officer, Cloudbreak, commented, "CBT-001 has taken a significant step closer to validating the Multi-Kinase Inhibitor platform to treat pterygium in a Phase 3 study design by simultaneously inhibiting multiple receptor tyrosine kinases, including PDGF, VEGF, and FGF. CBT-001 addresses the root cause of this fibrovascular disease rather than merely treating symptoms."
Cloudbreak has traded between HK$1.12 and HK$9.74 over the last year. Cloudbreak shares closed Thursday at HK$1.22, up 3.39% on the Hong Kong Stock Exchange.
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