Cloudbreak Pharma has announced positive topline results from its phase II trial of CBT‑004, a novel ophthalmic eye drop designed to treat vascularized pinguecula. The trial demonstrated that CBT‑004 met its primary endpoint, showing a statistically significant reduction in conjunctival redness at Day 28 compared with vehicle. The higher dose of CBT‑004 also showed early efficacy by Day 7, with effects sustained through the treatment period.

Vascularized pinguecula is a common, yet often overlooked, ocular surface condition associated with chronic inflammation, eye redness, discomfort and cosmetic concerns.¹ There are currently no approved therapies specifically targeting this condition.² If approved, CBT‑004 could represent the first targeted treatment option, addressing a clear unmet need for patients experiencing both clinical symptoms and visible eye redness.

The phase II trial was a multicenter, randomized, double-masked, vehicle-controlled study involving 88 adult participants with vascularized pinguecula and conjunctival hyperemia. Both concentrations of CBT‑004 produced significant improvements not only in clinician-assessed redness but also in patient-reported symptoms, including burning, itching, discomfort and foreign-body sensation. The treatment was well tolerated, with no treatment-related adverse events reported and no significant changes in visual acuity or intraocular pressure.

Cloudbreak Pharma plans to advance CBT‑004 into phase III development and initiate regulatory discussions with the FDA to define the next steps toward approval.

References:

1. Eltis M. Pingueculae and their clinical implications. CRO. 2017;22:10–3.
2. Ahn SJ, Shin KH, Kim MK, et al. One-Year Outcome of Argon Laser Photocoagulation of Pinguecula. Cornea. 2013; 32:971-975

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Citation: Positive phase II data announced for CBT‑004 in vascularized pinguecula. touchOPHTHALMOLOGY.com. 21 July 2025.