Cloudbreak Pharma has announced positive topline findings from a Phase 2 clinical study assessing its investigational ophthalmic solution, CBT-004, in patients diagnosed with vascularized pinguecula and associated conjunctival hyperemia. Based on these results, the company plans to initiate discussions with the U.S. Food and Drug Administration regarding regulatory steps toward potential approval.
CBT-004 targets vascular endothelial growth factor receptors (VEGFRs) and platelet-derived growth factor receptors (PDGFRs). Cloudbreak is exploring this approach as a method to reduce abnormal blood vessel formation linked with late-stage pinguecula. This eye condition is characterized by elevated, yellowish tissue on the surface of the eye. When inflamed, it can lead to symptoms such as eye redness, itching, pain, and discomfort.
The double-masked, randomized, vehicle-controlled Phase 2 trial enrolled 88 adult participants with vascularized pinguecula and visible eye redness. Subjects were randomized to receive one of two concentrations of CBT-004 or a placebo, applied as eye drops over a period of 28 days. The primary objective was to measure changes in conjunctival hyperemia on Day 28, using standardized digital imaging techniques assessed by an independent reading center.
Cloudbreak reported that both concentrations of CBT-004 achieved statistically significant improvements in conjunctival hyperemia compared to placebo. Notably, improvements in the higher concentration group were observed as early as Day 7 and continued through the entire treatment period.
In addition to the primary endpoint, the study also captured patient-reported outcomes related to symptoms. These included burning or stinging, itching, foreign body sensation, eye discomfort, and pain. Cloudbreak stated that both concentrations of CBT-004 showed statistically significant improvements in all five symptom categories compared to the placebo group.
No treatment-related adverse events were observed during the study. According to Cloudbreak, most adverse events were mild to moderate in severity. There were also no clinically meaningful changes noted in either visual acuity or intraocular pressure over the course of the trial.
Commenting on the study, Dr. John Hovanesian, Clinical Professor of Ophthalmology, stated: “There is a significant unmet need for patients suffering from symptomatic pinguecula, as current therapies are largely off-label and may carry safety concerns with long-term use.”
Dr. Sherif El-Harazi, Medical Director at Global Research Management and one of the principal investigators in the trial, commented that he observed consistent improvements in both objective redness and patient discomfort throughout the study and noted the strong safety profile of CBT-004.
Cloudbreak has announced that it will provide further information on the Phase 3 trial’s structure and timing in the coming months. The company is pursuing approval of CBT-004 through the 505(b)(2) regulatory pathway, supported by data from Pfizer’s oral VEGFR inhibitor, Inlyta.
If authorized, CBT-004 would be the first approved treatment specifically developed for vascularized pinguecula. Current approaches involve the use of lubricating drops and off-label application of nonsteroidal or steroid-based eye treatments.
Cloudbreak recently listed its shares in Hong Kong. The company has designated CBT-001 and CBT-009, aimed at treating pterygium and juvenile myopia, respectively, as its core programs. Most proceeds from the initial public offering are allocated to these core products. CBT-004 is part of Cloudbreak’s broader development portfolio.
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