Announcement • Apr 24
Cloudbreak Pharma Inc. Announces Multi-Kinase Inhibition Platform and Ongoing Clinical Programs At Eyecelerator At ARVO 2026
Cloudbreak Pharma Inc. announced an upcoming presentation highlighting its MKI platform and related clinical programs at Eyecelerator at ARVO 2026, which is being held May 1, 2026, in Denver, CO. MKIs uniquely block multiple receptor tyrosine kinases (RTKs) simultaneously, addressing the inflammatory, vascular, and fibrotic causes of serious, underserved front-of-the-eye diseases. Lead MKI candidates, CBT-001 and CBT-004, demonstrated statistically significant and clinically meaningful efficacy in Phase 2 studies and have the potential to be the first FDA-approved therapies for their respective indications. Topline data from the Phase 3 study of lead candidate, CBT-001 for the treatment of pterygium, is on track for the third quarter 2026. The presentation provides an overview of Cloudbreak’s Multi Kinase Inhibitor (MKI) discovery platform and its unique mechanism of action that blocks multiple receptor tyrosine kinases (RTKs) simultaneously, including vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF) and fibroblast growth factor (FGF), and addresses the inflammatory and fibrovascular causes of front-of-the-eye diseases in addition to their symptoms. Cloudbreak’s lead candidate, CBT-001 is in Phase 3 development for pterygium, a serious and potentially sight-threatening disease that is estimated to impact 15 million people in the U.S. alone. In a Phase 2 study, treatment with CBT-001 led to a statistically significant reduction in the mean grade change from baseline in pterygial vascularity. There are currently no FDA-approved disease-modifying treatments for pterygium. Most patients are treated for their symptoms using artificial tears, prescription dry eye products and/or off-label NSAIDs or corticosteroids, with significant limitations for long-term use. For more severe cases, approximately 100,000 patients annually elect to have surgery, at a cost of $11,500 per procedure, and recurrence rates are estimated to be as high as 38%. Pinguecula is a round, yellowish, elevated tissue that develops on the surface of the eye. The condition is very common among people with increased UV light exposure and increasing age. The condition impacts over a billion people worldwide, including 50 million people in the US alone. Of those, 15 million are seen annually by an eye doctor, and 3.9 million are formally diagnosed each year by an ophthalmologist or optometrist. When the tissue becomes vascularized or inflamed, it can produce a number of symptoms including ocular redness, discomfort and pain, foreign body sensation and tearing and itching. Depending on the location and size of the pinguecula, it may also make wearing contact lenses uncomfortable or impossible. There are currently no FDA-approved pharmacological treatments for pinguecula. To treat some symptoms, such as dry eye and foreign body sensation, lubricating eye drops may be used. For pinguecula that are larger or inflamed, non-steroidal anti-inflammatory drugs or corticosteroids are used, although the former can be associated with corneal complications, while the latter is associated with glaucoma and cataract formation. CBT-001 is a novel, multi-kinase inhibitor (MKI) eye drop being developed for the treatment of pterygium, a common ocular surface disease with no FDA-approved drug therapies. Currently in Phase 3 clinical trials across multiple regions, CBT-001 is designed to target the underlying fibrogenic and angiogenic drivers of the disease rather than just providing symptomatic relief. In earlier studies, the therapy demonstrated meaningful reductions in lesion growth, vascularity, and ocular redness, with a favorable safety profile. If approved, CBT-001 has the potential to become the first pharmacologic treatment for pterygium, potentially delaying or eliminating the need for surgery and addressing a significant unmet medical need.
