Cloudbreak Pharma Announces Positive Phase 2 Results for CBT-004 in Patients with Vascularized Pinguecula

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

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 one of two concentrati`ons of CBT-004, or vehicle. 

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

No treatment-related adverse events were observed. Most adverse events were mild to moderate. No clinically meaningful changes in visual acuity or intraocular pressure were reported.

According to Cloudbreak, vascularized pinguecula affects millions of Americans and represents a substantial unmet medical need in ophthalmology. This common, benign conjunctival growth can become problematic when it develops abnormal blood vessels and inflammation, which can lead to persistent redness, irritation, pain, and foreign body sensation. Current management options are limited, with many patients relying on off-label corticosteroids or surgical excision, both of which carry significant limitations and potential complications.