Cloudbreak Pharma Announces Launch of Cloudbreakpharma.com to Raise Awareness of its Pipeline of Novel First-in-Class Therapeutics to Treat Serious Underserved Ophthalmic Diseases
Lead candidate, CBT-001 for the treatment of pterygium, a multi-billion-dollar addressable market, is in mid-Phase 3 with initial topline data anticipated in Q3 2026
Second asset, CBT-004 for the treatment of pinguecula, is Phase 3-ready following a successful End-of-Phase-2 meeting with FDA and alignment on a path forward
IRVINE, Calif., April 09, 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 the launch of its new website, www.cloudbreakpharma.com.
The newly launched website is a critical component of Cloudbreak’s recently initiated U.S. growth strategy, designed to raise awareness of its pipeline of novel first-in-class therapeutics in development to treat serious, underserved front-of-the-eye diseases. It serves as a comprehensive resource for all stakeholders, including people with fibrovascular corneal disease, potential investors and partners, and the broader ophthalmic community, to stay informed about the company’s programs.
Cloudbreak’s lead asset, the eye drop CBT-001, is in mid-Phase 3 as a potential treatment for pterygium, a potentially sight-threatening disease that impacts 15 million people in the U.S. alone. The company’s second asset, the eye drop CBT-004, is entering Phase 3 as a potential disease modifying treatment for pinguecula, which is estimated to impact half of people over the age of 70, or 50 million people in the U.S. alone. Cloudbreak is also advancing a broad pipeline of additional high-value technologies with pre-clinical through Phase 3-ready product candidates.
Abu Abraham, MD, Chief Medical Officer of Cloudbreak, stated, “As we rapidly approach a critical data readout for our lead Phase 3 asset, CBT-001, we believe now is the ideal time to raise awareness of our company across the U.S. medical and investment communities with the launch of our new website. Our novel technologies, leading with our MKI platform that uniquely inhibits multiple receptor tyrosine kinases (RTKs) and addresses the root cause of disease and not just the symptoms, have the potential to help millions of patients globally while creating enduring value for our company. With this enhanced digital presence, we look forward to deeper engagement with all constituents as we efficiently advance these highly differentiated programs.”
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 limited success 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 medical 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 mid-Phase 3 clinical trials across multiple regions, CBT-001 is designed to target the underlying fibrovascular 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 platelet-derived growth factors which are responsible for blood vessel maintenance. 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 KHEX 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
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