Cloudbreak Pharma Inc.'s CBT-004 indicated for the treatment of vascularised pinguecula has completed Phase II clinical trials in the United States
Cloudbreak Pharma Inc. has completed the Phase II clinical trial investigating CBT-004 for the treatment of vascularized pinguecula in the United States in April. Preliminary results demonstrated excellent ocular and systemic safety profile. The primary efficacy endpoint and multiple secondary endpoints were positive and met the set requirements.
Cloudbreak Pharma Inc. is an innovation-driven clinical-stage ophthalmology biotechnology company dedicated to the development of novel and differentiated treatments. Cloudbreak was founded in 2015 in Irvine, California, USA. The companyis headquartered in Irvine and has established operations in Mainland China and Hong Kong. The company is committed to in-house discovery, development and commercialization of first-in-class and best-in-class ophthalmic therapies to address global unmet medical needs. Cloudbreak has established a broad and innovative pipeline of eight drug candidates covering major anterior and posterior ophthalmic diseases, with four clinical-stage drug candidates and four pre-clinical stage drug candidates.
CBT-004, a multi-kinase inhibitor targeting VEGFRs and PDGFRs, is formulated as a topical ocular eyedrop indicated for the treatment of vascularised pinguecula.
Pinguecula is a round, yellowish, elevated tissue that develops on the conjunctiva adjacent to the cornea. In general, an asymptomatic pinguecula requires no treatment, but its yellowish and raised contour can cause ocular surface irritation. When the lesion becomes vascularised and/or inflamed, it may lead to symptoms of ocular hyperaemia, discomfort, pain, foreign body sensation, tearing, and itching. There is no FDA-approved therapy for the treatment of vascularised pinguecula.
CBT-004 received FDA approval for Phase II clinical trials for the treatment of vascularised pinguecula in September 2023. This clinical trial was completed in the United States in April 2025. Preliminary data analysis demonstrateed excellent ocular safety profile. The primary efficacy endpoint of this study was conjunctival hyperemia, which met the expected outcome. Both CBT-004 treatment groups showed statistically significant reductions in conjunctival hyperemia scores compared to the placebo group. A dose-response was observed; the high-dose group performed better than the low-dose group. Furthermore, multiple secondary efficacy endpoints also showed statistically significant differences between the treatment groups and the placebo group, demonstrating meaningful clinical effects. CBT-004 has previously demonstrated excellent efficacy and safety profiles in both non-clinical pharmacodynamic animal models and toxicology studies.
According to the F&S Report, the patient population of vascularised pinguecula reached 1,161.1 million in 2023. The patient population of vascularised pinguecula in the United States reached 45.7 million in 2023. The patient population of vascularised pinguecula in China reached 207 million in 2023. The F&S report also mentions that the global market size of vascularised pinguecula drug therapies is expected to reach US$1,539.3 million in 2033. The market size of vascularised pinguecula drug therapies in the United States and China are expected to reach US$940.6 million and US$92.2 million in 2033, respectively.
