CBT-001

Patients reported being unable to lead normal work and social lives due to unpredictable and untreatable nature of pterygium, according to data presented at American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting IRVINE, Calif.--(BUSINESS WIRE)-- Cloudbreak Pharma, a clinical stage biotechnology company developing ophthalmic drugs for common eye diseases with few treatment options, shared new data from a company-supported survey highlighting the patient burden of pterygium at the annual ASCRS meeting in Boston. Pterygium is an ocular disease commonly referred to as “surfer’s eye,” which can result from exposure to high levels of UV radiation.1 The cross-sectional survey revealed 50 percent of respondents reported that pterygium had a considerable impact on their lives, often interfering with their ability to perform daily activities.2 More than half of patients surveyed also reported that environmental factors such as wind, dry or hot weather, direct sun and pollen exacerbate their symptoms and make it difficult to spend time outdoors.2 Additionally, patients reported discomfort associated with air conditioning, so spending time indoors can also pose a challenge.2,3 Pterygium is a fibro-vascular growth that extends from the conjunctiva to the corneal surface.4,5 It affects roughly 15 million people in the U.S.,6 and can cause eye redness, irritation, dryness, tearing and foreign body sensation.5,7 Only about 1 in 6 patients have been diagnosed.6 Vision can be impaired in moderate and severe forms of pterygium.1 “Pterygium is far more common and has far more impact on patients – than implied by the casual name, ‘surfer’s eye.’ Chronic symptoms can impose a daily burden on people grappling with the disease, and unfortunately many people who experience symptoms face challenges receiving a formal diagnosis,” said Abu Abraham, Chief Medical Officer of Cloudbreak Pharma. “Cloudbreak Pharma recognizes the urgent and growing need for new non-surgical treatment options to address the debilitating symptoms associated with pterygium and help delay or avoid the need for surgery for these patients for whom there have been so few options.” There is no pharmacological treatment approved for pterygium, leading many people living with the ailment to turn to over-the-counter topical treatments that may only provide symptomatic relief.8 Patients with moderate to severe pterygium may turn to surgical intervention, but excision does not always prevent recurrence, can damage the eye, and may not correct vision, redness, and irritation.7 “Patients surveyed reported that physicians may not recognize the breadth of burden pterygium has on their lives,” said Dr. Daniel Terveen, ophthalmologist at Vance Thompson Vision in Sioux Falls, South Dakota. “Simple tasks like putting in contact lenses, applying makeup and using a computer or phone are made significantly more difficult, if not impossible, for those with pterygium. As ophthalmologists, we need to listen closely to our patients and coordinate with optometrists to fully understand the impact of pterygium. I am hopeful that research into more effective, non-surgical disease-modifying treatment options can help us address their unmet needs.” The survey was conducted in volunteers for a multi-center Phase 3 clinical trial enrolling people with a known pterygium of ≥1.2 mm and conjunctival hyperemia (measured on a scale of 0-4) in the U.S.2 Additional findings further illustrate the burdensome challenges faced by people living with pterygium:2 Unpredictability of symptoms and lack of effective pharmacological treatment options are driving patient frustration – Despite trying eye drops for symptomatic relief of pterygium, many respondents reported low satisfaction with available treatment options and said relief was only temporary. Patients experience challenges learning about pterygium and building relationships with their care providers. Roughly 80 percent of survey respondents reported such challenges while being diagnosed. When patients seek care, they can be diagnosed quickly – Although 50 percent of survey respondents did not seek care for 2+ years from symptom onset, most were diagnosed within one month after an office visit with an HCP. A Phase 2 clinical trial evaluating the safety, efficacy and pharmacokinetics of Cloudbreak Pharma’s CBT-001, an investigational multi-kinase inhibitor for the treatment of pterygium, showed promising results, highlighting its potential to reduce lesion length and decrease pterygia vascularity for patients with pterygium. The treatment candidate is currently being investigated in Phase 3 clinical studies to determine its ability to slow or stop disease progression and potentially eliminate or postpone the need for eye surgery for patients with pterygium. If the treatment is proven to be safe and effective, and ultimately approved by the U.S. Food and Drug Administration, it would be a first-in-class treatment option for pterygium and eliminate or postpone the need for eye surgery. More information about this trial is available here: Safety and Efficacy of CBT-001 Ophthalmic Solution in Patients With Pterygium. Survey Methodology This non-interventional, cross-sectional survey was conducted in volunteers for a multi-center Phase 3 clinical trial enrolling people with a known pterygium of ≥1.2 mm and conjunctival hyperemia (measured on a scale of 0-4) in the U.S. Survey participants who did not meet inclusion criteria due to mild to moderate conjunctival hyperemia in the Phase 3 trial (scores 0-2 during the screening visit) were recruited to participate in an online quantitative and qualitative survey about the burden of disease. The survey was conducted between September 8-December 29, 2023, and offered in English and Spanish. Key topics in the survey included patient journey (e.g., onset, diagnosis and treatment of pterygium) and the impact of the disease (e.g., ocular signs and symptoms, vision impact/changes, social impact and environmental factors) on patients’ lives as pterygium progresses. Topics for inclusion were informed by previously conducted qualitative research interviews with physicians and patients. The survey was designed with multiple-choice questions, rating questions and open-ended questions.2 About Pterygium Pterygium is a common disease affecting an estimated 15 million people in the U.S.6 It is a whiteish or pinkish, wing-shaped overgrowth of tissue on the surface of the eye that encroaches onto the cornea.4 Pterygium affects the way the eye looks and feels, and in moderate or severe cases, can also induce astigmatism.1 Patients commonly deal with the feeling of having a foreign body sensation in their eye, redness, sensitivity to light, watery eyes, itching, grittiness and other symptoms that may render them self-conscious and unable to perform work and daily tasks, as well as spend time outdoors.1,7,2 Pterygium can affect one or both eyes.1 Pterygium tends to impact people who are:4,5,7,9 ≥40 years of age Exposed to high levels of UV radiation Living and/or working close to the equator Exposed to some environmental factors (e.g., low-humidity, wind or dust) About Cloudbreak Pharma Cloudbreak Pharma is a clinical stage biotechnology company developing ophthalmic drugs for common eye diseases with few treatment options. Founded by scientists with the expertise to craft superior drug formulations and identify new mechanisms of action, Cloudbreak Pharma is working to transform large, complicated molecules into formulations that can pass through the eye barrier without having to inject them. The Cloudbreak pipeline is composed of candidates targeting several ophthalmic diseases that, while not blinding, often inhibit people from fully participating in life. Eye health is the future. We help people see theirs. Pterygium (Surfer’s eye): Diagnosis, symptoms & treatment. Cleveland Clinic. (n.d.). Gandhi, R., (n.d.). Pterygium Patient Burden Survey Identifies Gaps in Care and the Need for Nonsurgical Treatments. ASCRS Expo Planner. Ang, B. (2024, January 15). Pterygium / Pterygia. Vision and Eye Health. Retrieved March 26, 2024, from Shahraki, T., Arabi, A., & Feizi, S. (2021, May 31). Pterygium: An update on pathophysiology, clinical features, and Management. Therapeutic advances in ophthalmology. Chu, W. K., Choi, H. L., Bhat, A. K., & Jhanji, V. (2020, June). Pterygium: New insights. Eye (London, England). Abraham A, et al. Poster presented at: Association for Research in Vision and Ophthalmology Annual Meeting; April 23-27, 2023, New Orleans, LA, US. Sarkar, P. (2023, August 25). Pterygium. StatPearls [Internet]. Anthony, K. (2019, January 8). Pterygium surgery: Procedure, Recovery Time, and more. Healthline. Liu, L. (2013, November 19). Geographical prevalence and risk factors for pterygium: A systematic review and meta-analysis. National Library of Medicine. Retrieved March 26, 2024, from View source version on businesswire.com: Contacts Chinese Media Thomas Au au_thomas@cloudbreakpharma.com U.S. Media Mary Powers mary.powers@syneoshealth.com Source: Cloudbreak Pharma View this news release online at: