Cloudbreak Pharma Announces Final Patient Visit for 12-Month Efficacy Endpoint in Phase 3 Study of CBT-001 as a Potential Treatment for Pterygium

Milestone achievement advances potential first FDA-approved disease-modifying therapy for pterygium, a condition affecting just under one billion people globally, including 15 million people in the U.S.

Topline data anticipated in Q3 2026

IRVINE, Calif., June 04, 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 that the final patient has completed the 12-month visit, the primary efficacy endpoint for pterygium lesion size reduction as well as bothersome ocular symptoms score in its Phase 3 clinical trial for CBT-001.

This achievement represents a significant milestone in this development program and positions Cloudbreak to deliver top-line 12-month efficacy data in the third quarter of 2026. Topline data, if positive, could support multiple simultaneous commercial filings and could change the current “surgery only” treatment paradigm, if approved.

“The completion of the final 12-month endpoint visit is a critical achievement for CBT-001 and takes us a significant step closer to validating our Multi-Kinase Inhibitor platform approach to treating pterygium in a rigorously designed Phase 3 study,” said Abu Abraham, MD, Chief Medical Officer at Cloudbreak Pharma. “By simultaneously inhibiting multiple receptor tyrosine kinases, including PDGF, VEGF and FGF, CBT-001 addresses the root cause of this fibrovascular disease rather than merely treating symptoms. Our Phase 2 data already demonstrated significant disease modification, and we are confident that the science behind the MKI platform will translate into meaningful clinical benefits for patients who currently lack any FDA-approved drug therapy options for this potentially sight-threatening condition.”

Patient enrollment for this Phase 3 trial began in the U.S. in June 2022, expanded to China in September 2023, and subsequently to New Zealand, Australia, and India in May 2024, May 2024, and July 2024, respectively. Total enrollment of 660 patients was completed in May 2025. The trial is a multicenter, double-masked, randomized, vehicle-controlled study evaluating two doses of CBT-001 emulsion administered twice daily over 24 months. Efficacy is assessed at Month 3 and Month 12, with endpoints focused on reducing conjunctival hyperemia caused by the vascularized lesion and preventing pterygium progression.

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 just under one billion people globally, including 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 in the U.S.

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 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 angiogenic and fibrogenic drivers of the disease rather than just providing symptomatic relief. In earlier studies, the therapy demonstrated meaningful reductions in lesion size, 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 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/

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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

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