The final patient has completed a 12-month visit, during which the primary efficacy endpoints of CBT-001—the degree of pterygium lesion reduction and ocular discomfort symptom scores—were evaluated in the Phase 3 multi-regional clinical trial.
CBT-001 is one of the group's core products, a potential first-in-class drug utilizing a multi-kinase inhibitor that targets vascular endothelial growth factor receptor, platelet-derived growth factor receptor, and fibroblast growth factor receptor. It is intended for preventing the progression of pterygium, reducing conjunctival hyperemia, and alleviating symptoms associated with the condition.
Pterygium is an abnormal growth of tissue on the eye's surface that can cover the cornea. It affects nearly one billion people globally, particularly those with prolonged exposure to ultraviolet light. This progressive fibrovascular growth often causes persistent redness, irritation, a foreign body sensation, and can lead to astigmatism and vision impairment.
Also known as nintedanib free base, CBT-001 is a topical ophthalmic emulsion currently in a Phase 3 multi-regional clinical trial. According to an independent market research report prepared for the company's prospectus, there are currently no globally approved drugs for treating pterygium, with surgical excision being the only existing treatment option. This addresses a significant and unmet medical need.
CBT-001 is being developed under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, a regulatory pathway commonly used by ophthalmic biotech companies. This allows the group to leverage the validated safety and efficacy data of a previously approved drug, potentially accelerating the development timeline and reducing costs.
The company initiated patient recruitment for this Phase 3 multi-regional clinical trial in the United States in June 2022 and expanded recruitment to China in September 2023. Further trials were launched in New Zealand, Australia, and India in May 2024, May 2024, and July 2024, respectively, as part of the global Phase 3 program to evaluate CBT-001's efficacy.
In May 2025, the company completed patient recruitment across all five jurisdictions, enrolling a total of 660 patients. The Phase 3 multi-regional clinical trial is progressing, and the company anticipates obtaining preliminary efficacy and safety data in the foreseeable future.
The company views the completion of this final 12-month endpoint visit as a significant milestone in the development of CBT-001. This achievement will enable the company to release preliminary 12-month efficacy data in the third quarter of 2026.
Positive preliminary data would support multiple commercialization applications simultaneously. If approved, the drug has the potential to transform the current treatment paradigm, which relies solely on surgery.
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