Cloudbreak Pharma Announces Presentation on its Multi-Kinase Inhibition (MKI) Platform and Ongoing Clinical Programs at Eyecelerator @ ARVO 2026
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, on track for Q3 2026
IRVINE, Calif., April 22, 2026 (GLOBE NEWSWIRE) -- Cloudbreak Pharma Inc., (HKEX 2592), a clinical stage ophthalmic drug company leveraging its proprietary Multi Kinase Inhibitor (MKI) discovery platform to develop first-in-class and best-in-class therapeutics, today announced an upcoming presentation highlighting its MKI platform and related clinical programs at Eyecelerator @ ARVO 2026, which is being held May 1, 2026, in Denver, CO.
“Pterygium and pinguecula are common degenerative eye conditions that can be serious, and in the case of pterygium, potentially sight threatening. Despite affecting very large patient populations, there are currently no FDA-approved therapies that address the underlying causes of these diseases,” stated Dr. Francis S. Mah, MD, Director of Cornea and External Disease at Scripps Clinic Medical Group in La Jolla, CA. “Cloudbreak’s novel MKI platform represents a new class of ophthalmic topical therapy, that uniquely blocks multiple receptor tyrosine kinases (RTKs) simultaneously. This multi-target approach may enable clinical candidates such as CBT-001 and CBT-004 to offer disease-modifying benefits for our patients.”
Abu Abraham, MD, Chief Medical Officer at Cloudbreak, added, “We are pleased to highlight our MKI platform at Eyecelerator, a leading ophthalmology innovation conference focused on advancing new technologies and treatments in eye care. Events like this enable us to raise awareness of the seriousness of pterygium and pinguecula, the unmet need that exists for the many millions of patients who are affected, and the potential of our MKI platform to fundamentally alter the disease trajectory. We anticipate top-line Phase 3 data for CBT-001 as a potential treatment for pterygium in the third quarter of this year, and we are preparing to initiate a Phase 3 study of CBT-004 in pinguecula in the first quarter of 2027.”
Presentation details:
Title: Multi-Kinase Inhibition: A New Focus for the Anterior Segment
Presenter: Francis S. Mah, MD
Breakout: Anterior Segment / Glaucoma
Time: 1:36-1:41 pm MDT
This 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 (p<0.001) after four weeks of treatment. Additionally, there was a reduction in the size of the lesion compared with vehicle-treated subjects (p<0.014). Data from the first Phase 3 study of CBT-001 are anticipated in the third quarter of 2026.
The Company’s second clinical candidate, CBT-004, is Phase 3-ready as a treatment for pinguecula, a condition that impacts over a billion people worldwide, including 50 million people in the U.S. alone. In a Phase 2 study, treatment with CBT-004 led to statistically significant and clinically meaningful reductions in hyperemia and vascularity as well as foreign body sensation as early as day 7. A Phase 3 multi-regional study is anticipated to commence in the first quarter of 2027.
About Eyecelerator
Eyecelerator, is a partnership between ASCRS (American Society of Cataract and Refractive Surgery) and the American Academy of Ophthalmology to connect entrepreneurs, investors, businesses and ophthalmologists to accelerate ophthalmic innovation and improve patient outcomes. For more information, visit https://eyecelerator.com.
About Pterygium
Pterygium is a triangular fibrovascular growth on the cornea, connected to the conjunctiva. It is commonly caused by excessive UV exposure and can lead to redness, irritation, foreign body sensation, and, with continued progression, potentially serious vision problems. The company estimates that pterygium impacts as many as 15 million people in the U.S. alone. Of those, approximately 7.5 million are seen annually by an eye doctor, and 3.7 million are formally diagnosed each year by an ophthalmologist or medical optometrist.
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%.
About Pinguecula
Pinguecula (pin·gwek·yoo·luh) 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.
About CBT-001
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.
About CBT-004
CBT-004 is a novel, preservative-free topical ophthalmic solution containing a potent VEGF receptor inhibitor. CBT-004 also inhibits PDGF receptors, which play key roles in blood vessel maintenance and tissue remodeling. By inhibiting these growth factors and modifying the disease, the formulation is specifically designed to address the hyperemia and abnormal vascularization associated with the pinguecula lesion. The preservative-free formulation is designed to minimize potential ocular surface toxicity, positioning it for possible chronic use in this condition affecting the delicate ocular surface.
About Cloudbreak
Cloudbreak Pharma is a clinical stage ophthalmic drug company with a proprietary technology, Multi Kinase Inhibitors (MKI), that is de-risked with human clinical results and is uniquely suitable for both front-of-eye and back-of-eye diseases.
Under the MKI platform, Cloudbreak’s lead asset, the eye drop CBT-001, is in mid-Phase 3 in multiple regions for the treatment of pterygium, a disease impacting 15 million people in the US alone. Its second asset, CBT-004, is entering Phase 3 for pinguecula, a disease impacting about half of all people over age 70. CBT-001 and CBT-004 will potentially be the first and only FDA-approved drug therapies for these high-value conditions. The Company has additional technologies with pre-clinical through Phase 2 product candidates.
The Cloudbreak team is comprised of experienced ophthalmologic scientists and business professionals that are uniquely qualified to bring product candidates from pre-clinical to NDA approval.
For more information, visit: https://cloudbreakpharma.com/
For an informative video, please click here.
Forward Looking Statements
This press release contains forward-looking statements regarding the future performance, plans and prospects of Cloudbreak Pharma, Inc. (with effect from 3 July 2025, shares listed on the Main Board of The Stock Exchange of Hong Kong Limited (the “HKEX”)).
These statements may include research and development (R&D) activities, clinical trial progress and outcomes, regulatory submissions, timelines and approvals, manufacturing and supply operations, product launches and partnerships and/or financial outlook and business strategy.
All forward-looking statements are based on management’s current expectations and assumptions only as of the date hereof. Actual results may differ due to various factors, including clinical or regulatory outcomes (e.g., US or other markets), competitive developments and market dynamics, and/or economic or operational uncertainties.
Cloudbreak Pharma, Inc. undertakes no obligation to update or revise any forward-looking statements to reflect subsequent circumstances, except as required by law. The information contained in this presentation may not be complete and may not contain all particulars required to be disclosed by us under the Rules Governing the Listing of Securities on the HKEX and the Securities and Futures Ordinance (Chapter 571 of the Laws of Hong Kong).
Investors or interested parties should review our public filings with the HKEX and our company’s website (cloudbreakpharma.com) for additional information.
Contacts:
For investors:
Eric Ribner, LifeSci Advisors
eric@lifesciadvisors.com
For partnering opportunities:
partners@cloudbreakpharma.com
Legal Disclaimer:
EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
