Announcement • Jun 22
Cloudbreak Pharma Announces Results of First-Of-Its-Kind Patient Survey on Pinguecula and Provides Update on Cbt-004 Clinical Development
Cloudbreak Pharma Inc. 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. 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. Cloudbreak Pharma observed impressive efficacy in its 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. Cloudbreak Pharma plans to build upon these compelling results as it initiates 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. Pinguecula 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. 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. 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.
