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Both doses of CBT-001 demonstrated statistically significant improvements in conjunctival hyperemia at Month 3 versus vehicle (p<0.001), with improvement observed as early as Week 2 and maintained through Month 12

Both doses also demonstrated statistically significant prevention of progression of pterygium lesion length at Month 12 versus vehicle (p<0.001)

Superficial punctate keratitis was reported in 20% of patients receiving CBT-001 0.1%, compared with 8% receiving vehicle; the majority of cases were resolved with the use of artificial tears

Company intends to meet with FDA as soon as practicable to review the study findings and discuss potential next steps

IRVINE, Calif., Nov. 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 topline results from its Phase 3 study of CBT-001 as a potential treatment for pterygium. Both doses of CBT-001 demonstrated statistically significant improvements versus vehicle in conjunctival hyperemia at Month 3 and prevention of progression of pterygium lesion length at Month 12. These findings mark the first time a drug has demonstrated disease-modifying activity in pterygium through a statistically significant improvement in hyperemia and lesion size. Additional analyses are ongoing.

Key data highlights:

• Conjunctival hyperemia: Both CBT-001 0.2% and CBT-001 0.1% administered twice daily demonstrated statistically significant improvement versus vehicle at Month 3 (p<0.001). This improvement was observed as early as Week 2 and maintained through every visit up to Month 12.
• Prevention of progression of pterygium lesion length: Both CBT-001 doses demonstrated statistically significant improvement versus vehicle at Month 12 (p<0.001). In terms of lesion size, the treatment-versus-vehicle benefit was approximately 10% of baseline. Notably, as of Month 12, the observed treatment effect had not yet reached a plateau.
• Safety: Superficial punctate keratitis was the most commonly reported adverse event in the CBT-001 0.1% group (20% versus 8% in the vehicle group), with most cases resolving following treatment with artificial tears. All other individual adverse events occurred in 2% or fewer patients in the 0.1% group. A similar adverse event profile was observed with the 0.2% dose, although at a higher incidence.
  
  

“Pterygium is a condition that impacts both vision and quality-of-life for millions of people and for which there are currently no FDA-approved drug therapies. We are encouraged by the performance of CBT-001 in this Phase 3 trial, which demonstrated consistent, statistically significant improvements in both conjunctival hyperemia and pterygium lesion length,” said Abu Abraham, MD, Chief Medical Officer at Cloudbreak Pharma. “CBT-001 has the potential to become the first disease-modifying therapy in pterygium, and we look forward to engaging with the FDA as soon as practical to determine next steps for this potential first-in-class therapy.”

Cloudbreak is conducting additional analyses of the Phase 3 results and intends to meet with the FDA to review the study findings and discuss potential next steps for the CBT-001 development program, including the clinical and regulatory implications of the results.

About the Phase 3 Trial
CS-301 (NCT05456425) is a multi-regional, double-masked, randomized, vehicle-controlled Phase 3 trial in patients with pterygium comparing two doses of CBT-001 ophthalmic emulsion (0.1%, 0.2%) administered twice daily over 24 months versus vehicle. The primary efficacy endpoints include reduction in conjunctival hyperemia related to the vascularized pterygium lesion at three months and prevention of pterygium progression at 12 months. The study protocol also includes a 12-month double-masked extension for an additional 12 months of safety data.

Enrollment began in the U.S. in June 2022 and expanded to China, New Zealand, Australia, and India. The topline results summary reports 659 patients: 164 assigned to CBT-001 0.1%, 329 to CBT-001 0.2%, and 166 to vehicle. The study included 58% male and 42% female participants.

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, dry eye, and, with continued progression, potentially serious vision problems. The company estimates that pterygium impacts just under one billion people globally, including 13 million people in the U.S. alone. Of those, approximately 6.5 million are seen annually by an eye doctor, and 2.5 million are formally diagnosed each year by an ophthalmologist or optometrist that report into medical databases 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.

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 development 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 and durable reductions in pterygium vascularity, and ocular redness, with a favorable safety profile. If approved, CBT-001 has the potential to become the first pharmacologic treatment for pterygium, 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 Phase 3 clinical development in multiple regions for the treatment of pterygium, a disease impacting 13 million people in the US alone. Its second asset, CBT-004, had a successful EOP2 meeting with the FDA and is entering Phase 3 for pinguecula, a disease impacting about half of all people over age 70. If approved, 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 including a Semi-fluorinated Alkane Plus (SFA+) platform with pre-clinical through Phase 3-ready 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 announcement contains forward-looking statements regarding the future performance, plans and prospects of the Company. 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 the Company’s management’s current expectations and assumptions only as at the date of this announcement. The financial and other data relating to the Group, as disclosed in this announcement, have not been audited or reviewed by its auditors. Actual results may differ due to various factors, including clinical or regulatory outcomes (e.g., U.S. or other markets), competitive developments and market dynamics, and/or economic or operational uncertainties.

Continued Suspension of Trading

All dealings in the shares of the Company have been suspended by the Hong Kong Stock Exchange as directed by the Commission since 9:00 a.m. on 10 September 2026 and will remain suspended until further notice.

Shareholders and potential investors of the Company should exercise caution when dealing in the securities of the Company.

Contacts:

For investors:
Eric Ribner, LifeSci Advisors
eric@lifesciadvisors.com

For partnering opportunities:
partners@cloudbreakpharma.com