CBT-004 Shows Positive Phase 2 Results in Pinguecula

Cloudbreak Pharma has announced encouraging topline results from its Phase 2 clinical trial evaluating CBT-004 ophthalmic solution in patients diagnosed with vascularized pinguecula and associated conjunctival hyperemia. The findings highlight a potential new treatment option for a condition with limited therapeutic choices and significant patient burden.

Study Design and Patient Enrollment

The Phase 2 study was a multicenter, randomized, double-masked, vehicle-controlled clinical trial involving 88 adult patients with vascularized pinguecula accompanied by conjunctival hyperemia. Participants were randomized to receive one of two concentrations of CBT-004 or vehicle over a 28-day treatment period.

Efficacy Outcomes: Improvements in Redness and Symptoms

Both concentrations of CBT-004 demonstrated statistically significant improvements in conjunctival hyperemia compared to vehicle at Day 28, the study’s primary endpoint. Hyperemia was objectively assessed by an independent reading center using digital imaging.

Notably, improvements were observed as early as Day 7 with the higher concentration of CBT-004, and this benefit was sustained through the full treatment period. In addition, both concentrations led to statistically significant improvements in five key patient-reported symptoms, including:

• Burning or stinging

• Itching

• Foreign body sensation

• Eye discomfort

• Ocular pain

Safety and Tolerability Profile

CBT-004 was well tolerated, with no treatment-related adverse events reported. Most adverse events were described as mild to moderate. Importantly, there were no clinically meaningful changes in visual acuity or intraocular pressure, further supporting the safety profile of the investigational therapy.

Addressing an Unmet Need in Ophthalmology

Cloudbreak Pharma emphasized that vascularized pinguecula affects millions of Americans and remains a substantial unmet need in ophthalmic care. While the condition is generally benign, it can become symptomatic when accompanied by abnormal blood vessel growth and inflammation, leading to chronic redness, irritation, pain, and a persistent foreign body sensation.

Currently, treatment options are limited. Patients often rely on off-label corticosteroids, which pose long-term safety concerns, or surgical excision, which carries procedural risks.