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 comprehensive market research survey examining the experience of patients diagnosed with pinguecula and assessing their interest in a new pharmaceutical treatment option.
The survey was conducted by an independent, third-party market research firm in April and May of 2026. A total of 1,020 U.S. adults between the ages of 35 and 80 who had seen an eye care professional in the prior five years were interviewed via an internet-based questionnaire.
Key Survey Findings:
- Approximately 10% of respondents self-identified as currently having pinguecula and were under the care of an eye doctor for the condition. This prevalence is consistent with published epidemiological data for moderate to severe pinguecula. For all stages of the disease, published sources indicate that incidence rises progressively with age, reaching approximately 50% of all older adults.
- Among this patient population, more than 3 out of 4 respondents rated pinguecula moderately or greatly bothersome. The primary drivers of discomfort reported were general ocular irritation, itchiness, and redness (hyperemia).
- Patients also identified key environmental triggers that worsened their symptoms. Leading factors included common everyday occurrences such as allergies, dry or hot weather conditions, excess light exposure, smoking, and wind.
- When asked about interest in a prescription pharmaceutical treatment option, given that no such FDA-approved therapy currently exists, patients rated their interest a 3.4 on the same 0-to-4 scale, reflecting moderate-to-great interest.
“These survey results confirm what clinicians have long observed in practice: pinguecula is a condition that meaningfully affects patients’ daily lives, and yet there are no FDA-approved pharmaceutical treatments developed specifically to address its signs and symptoms,” said Abu Abraham, MD, Chief Medical Officer at Cloudbreak Pharma. “These data highlight the significant unmet need that we are working to address with CBT-004. We observed impressive efficacy in our Phase 2 study, notably the statistically significant reductions in hyperemia and foreign body sensation from baseline that were seen as early as the first study visit on day seven. We plan to build upon these compelling results as we initiate a rigorous and efficiently designed Phase 3 program early next year.”
Cloudbreak Pharma intends to publish the full results of this survey in a peer-reviewed medical journal in the coming months.
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 a medical optometrist or ophthalmologist.
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 temporarily reduce 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-004
CBT-004 is a novel, preservative-free topical ophthalmic solution containing a potent, selective VEGF receptor inhibitor. By inhibiting VEGF-driven signaling, 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/
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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.
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