Cloudbreak Pharma Announces Successful End-of-Phase-2 Meeting and Alignment with FDA on Phase 3 Path Forward for CBT-004

CBT-004, if approved, would be the first and only treatment for pinguecula, an ophthalmic condition impacting more than 50 million people in the U.S. alone

In prior studies, CBT-004 demonstrated an ability to modify disease progression through a novel, multi-target mechanism of action

Phase 3 data from lead asset, CBT-001, as a potential treatment for pterygium anticipated in Q4 2026

IRVINE, Calif., Jan. 27, 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 results of a successful End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) regarding the late-stage development of CBT-004 for the treatment of pinguecula.

Francis Mah, MD, Director of Cornea and External Disease at Scripps Clinic Medical Group in La Jolla, CA, stated, “Pinguecula is a widely prevalent ocular disease characterized by a growth near the cornea that is prone to inflammation and abnormal vascularization, causing a ‘foreign body’ sensation in the eye that can interfere significantly with patient quality of life. The current standard-of-care, corticosteroids, addresses only symptoms and not the underlying disease, and presents safety challenges with longer-term use. In a prior rigorously designed Phase 2 study, CBT-004 addressed the most bothersome symptoms of pinguecula while also demonstrating an ability to modify the trajectory of the disease. I look forward to one day incorporating it into my own practice, if approved.”

Abu Abraham, MD, Chief Medical Officer at Cloudbreak, added, “We are extremely pleased to have completed a successful end-of-phase 2 meeting with FDA and reached alignment with the Agency on a reasonable and clear path forward for CBT-004 that includes endpoints that were previously achieved in our successful Phase 2 study. I would once again like to thank the patients and investigators who participated in our Phase 2 program, and I am optimistic that we will be able to replicate those compelling results in upcoming pivotal studies. We are well positioned to help the millions of people across the U.S. who suffer from this bothersome condition while at the same time creating significant value for our Company in this multi-billion addressable market.”

Phase 2 recap
The EOP2 meeting was supported by positive results from a multicenter, randomized, double-masked, vehicle-controlled Phase 2 study that enrolled 88 adult patients with vascularized pinguecula and associated conjunctival hyperemia. Participants were randomized to receive one of two concentrations of CBT-004, or vehicle.

Both investigated concentrations of CBT-004 demonstrated statistically significant improvements in conjunctival hyperemia compared to vehicle at Day 28, the primary endpoint, as assessed by an independent reading center using digital imaging. Significant improvements were observed with the higher dose of CBT-004 as early as the first scheduled study visit on Day 7. Benefits persisted through the 28-day treatment period for both CBT-004 concentrations, showing statistically significant improvements in five common patient-reported symptoms, including burning/stinging, itching, foreign body sensation, eye discomfort, and pain compared to vehicle.

No treatment-related adverse events were observed. Most adverse events were mild to moderate. No clinically meaningful changes in visual acuity or intraocular pressure were reported.

Anticipated Phase 3 study design
The primary efficacy endpoints for the Phase 3 studies will include a sign and symptom of pinguecula, both of which were statistically significant findings in the prior Phase 2 trial. The current plan is for Cloudbreak to conduct a Phase 3 program in which efficacy is assessed at three months, and safety is assessed at twelve months. The company is planning to complete remaining toxicity studies in 2026 and initiate the Phase 3 program in Q1 2027.

Notably, the Company continues to engage in dialogue with the FDA to determine if a path forward may exist to conduct a single, sufficiently powered pivotal study consistent with recent statements made by the FDA Commissioner.

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. Routinely diagnosed by optometrists and ophthalmologists, the condition likely impacts over 50 million people in the US and a billion people worldwide. When the tissue becomes vascularized or inflamed, it can produce a number of symptoms including ocular redness, discomfort and pain, foreign body sensation, tearing and itching. Depending on the location and size of the pinguecula, it may also make wearing contact lenses uncomfortable or impossible.

There is currently no pharmacological treatment for pinguecula approved by the FDA. 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. With few existing reliable options for symptom relief, there is a strong need for pharmacological treatment specifically designed to address this condition.

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, 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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