CBT-006 is a molecule developed by Cloudbreak Therapeutics that can sequester cholesterol. CBT-006 is a unique topical formulation following 505b(2) regulatory pathway. CBT-006 applied topically in repeat dosing as eye drops will dissolve cholesterol and other lipids deposited at the orifice of meibomian glands to improve meibum quality and meibomian gland health.
Clinical data shows that CBT-006 can quickly and significantly improve symptoms, and has long-lasting effects after stopping the drug, and its safety is excellent. CBT-006 also demonstrates statistical significance in improving dry eye symptoms.
According to patents of the company, CBT-006 is a beta-cyclodextrin derivative and the sole active pharmaceutical ingredient for treating the eye disease. From the wording of the patent, it is not clear which derivative is this lead candidate.
The upcoming clinical trial not recruiting 90 patients (NCT04884243) will target the following measures:
Primary Outcome Measures :
- Incidence of treatment-emergent adverse events [ Time Frame: 3 months ]Visual acuity, biomicroscopy, intraocular pressure, ophthalmoscopy
Secondary Outcome Measures :
- Ocular discomfort score (0-4) [ Time Frame: 3 months ]Change of the ocular discomfort score from baseline (Day 1) at Week 12; Score 0 is the most comfortable and 4 is the least comfortable