Cloudbreak Pharma Inc. announced positive topline results from its phase 2 clinical trial evaluating CBT-004 ophthalmic solution in patients with vascularized pinguecula and associated conjunctival hyperemia.

Both investigated concentrations of CBT-004 demonstrated statistically significant improvements in conjunctival hyperemia compared to vehicle at Day 28, as assessed by an independent reading center using digital imaging, the company said in a press release. Significant improvements were observed as early as Day 7 with the highest investigated concentration CBT-004, with benefits persisting through the 28-day treatment period. In addition, both CBT-004 concentrations showed statistically significant improvements in 5 common patient-reported symptoms including burning/stinging, itching, foreign-body sensation, eye discomfort, and pain compared to vehicle.

According to the company, no treatment-related adverse events were observed. Most adverse events were mild to moderate. No clinically meaningful changes in visual acuity or intraocular pressure (IOP) were reported.

The multicenter, randomized, double-masked, vehicle-controlled phase 2 study enrolled 88 adult patients with vascularized pinguecula and associated conjunctival hyperemia. Participants were randomized to receive 1 of 2 concentrations of CBT-004, or vehicle. The primary endpoint was the change from baseline in conjunctival hyperemia at Day 28, as measured by an independent reading center using standardized digital imaging protocols.

Based on these positive phase 2 results, the company said it plans to advance CBT-004 into phase 3 development and initiate discussions with the US Food and Drug Administration to establish the regulatory pathway toward potential approval, and anticipates providing updates on phase 3 study design and timing in the coming months.