Cloudbreak Pharma's Eye Drop Hits Phase 2 Milestone, Paving Way for Phase 3 Trial

Cloudbreak Pharmaceuticals has announced promising results from its phase 2 trial of CBT-004, an eye drop designed to treat vascularized pinguecula, setting the stage for a potential phase 3 study. The trial's success marks a significant step forward in addressing an unmet need in ophthalmology and bolsters the company's position in the competitive eye care market.

Phase 2 Trial Results

The phase 2 trial enrolled 88 adults with vascularized pinguecula and associated ocular redness. Participants received one of two doses of CBT-004 or a placebo for 28 days. The study's primary endpoint was met, with significant improvements in conjunctival hyperemia observed in both CBT-004 treatment groups compared to the control.

Key findings from the trial include:

• Significant improvements in conjunctival hyperemia were noted from Day 7 onward in the high-dose group.
• Patient-reported symptoms, including burning, stinging, itching, foreign body sensation, eye discomfort, and pain, showed statistically significant improvements compared to the placebo.
• No treatment-related adverse events were reported, with most adverse events being mild to moderate.
• No clinically meaningful changes in visual acuity or intraocular pressure were observed.

Mechanism of Action and Market Potential

CBT-004 targets vascular endothelial and platelet-derived growth factor receptors (VEGFRs/PDGFRs), aiming to reduce abnormal vascularity associated with late-stage pinguecula. This condition, characterized by yellowish, elevated tissue on the eye, can lead to inflammation, causing eye pain, itching, and redness.

If approved, CBT-004 would be the first drug specifically indicated for vascularized pinguecula. Current treatments are limited to lubricating eye drops and off-label use of nonsteroidal anti-inflammatory drugs or steroid eye drops. Cloudbreak believes there is a significant market opportunity for a safer and more effective treatment option.

Regulatory Strategy and Future Plans

Cloudbreak intends to pursue the 505(b)(2) regulatory pathway for CBT-004 in the United States, leveraging existing data on Pfizer's oral VEGFR inhibitor Inlyta to support their filing. This approach could potentially streamline the approval process.

The company plans to provide updates on the design and timing of its phase 3 trial in the coming months. This next step will be crucial in determining the drug's efficacy and safety profile in a larger patient population.

As Cloudbreak advances CBT-004, it continues to develop other assets in its pipeline, including CBT-001 for pterygium and CBT-009 for juvenile myopia. The recent listing of the company's shares in Hong Kong has provided additional funding to support these development efforts, with a significant portion of the IPO proceeds earmarked for their core products.