en.Wedoany.com Reported - Cloudbreak Pharma Inc. (Hong Kong Stock Exchange Code: 2592) announced that the Phase III clinical trial CBT-001 for the treatment of pterygium has completed the 12-month visit for the last patient. The primary efficacy endpoints of the trial are reduction in pterygium lesion size and improvement in bothersome ocular symptom scores. The company expects to report top-line 12-month efficacy data in the third quarter of 2026. If the data are positive, they will support simultaneous commercial applications in multiple regions and have the potential to change the current "surgery-only" treatment paradigm for pterygium.
Dr. Abu Abraham, Chief Medical Officer of Cloudbreak Pharma, stated that this is a key milestone for the CBT-001 program. CBT-001 targets the root cause of this fibrovascular disease by simultaneously inhibiting multiple receptor tyrosine kinases, including PDGF, VEGF, and FGF. The company's Phase II data have shown disease-modifying effects, and there are currently no FDA-approved drugs for treating this potentially vision-threatening condition.
The Phase III trial is a multicenter, double-blind, randomized, vehicle-controlled study evaluating two doses of CBT-001 emulsion administered twice daily for 24 months. Patient enrollment began in the United States in June 2022, subsequently expanded to China (September 2023), New Zealand, Australia, and India (May to July 2024), and completed enrollment of all 660 patients in May 2025. Efficacy assessments were conducted at months 3 and 12, focusing on reducing conjunctival hyperemia and preventing pterygium progression.
Pterygium is a triangular fibrovascular growth of the cornea connected to the conjunctiva, typically caused by excessive ultraviolet exposure. The company estimates that the condition affects nearly 1 billion people globally, including 15 million in the United States alone, with approximately 7.5 million clinic visits annually. There are currently no FDA-approved disease-modifying therapies, and over 100,000 patients undergo surgery each year for severe cases, costing $11,500 per procedure, with a recurrence rate of up to 38%.
CBT-001 is a novel multi-kinase inhibitor (MKI) eye drop designed to target the angiogenic and fibrogenic drivers of the disease. In earlier studies, the therapy showed reductions in lesion size, vascularity, and eye redness, with a favorable safety profile. Cloudbreak Pharma is a clinical-stage ophthalmic drug company, and its second asset under the MKI platform, CBT-004, is about to enter Phase III trials for the treatment of pinguecula.
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