Cloudbreak Pharma Inc. Announces Positive Phase 2 Results for CBT-004 in Patients with Vascularized Pinguecula
Novel preservative-free CBT-004 eye drop formulation demonstrates statistically significant improvements in conjunctival hyperemia and patient-reported symptoms with excellent safety profile
Article content
IRVINE, Calif. — Cloudbreak Pharma Inc. a clinical-stage ophthalmology company developing innovative therapies for ocular surface diseases, today announced positive topline results from its Phase 2 clinical trial evaluating CBT-004 ophthalmic solution in patients with vascularized pinguecula and associated conjunctival hyperemia.
Article content
Key Phase 2 Results
Article content
Primary Endpoint Achieved:
Article content
Both investigated concentrations of CBT-004 demonstrated statistically significant improvements in conjunctival hyperemia compared to vehicle at Day 28, as assessed by an independent reading center using digital imaging.
Article content
Rapid Onset and Sustained Efficacy:
Article content
Significant improvements were observed as early as Day 7 with the highest investigated concentration CBT-004 , with benefits persisting through the 28-day treatment period.
Article content
Significant Symptom Relief:
Article content
Both CBT-004 concentrations showed statistically significant improvements in five common patient-reported symptoms including burning/stinging, itching, foreign body sensation, eye discomfort, and pain compared to vehicle.
Article content
Excellent Safety Profile:
Article content
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.
Article content
Addressing a Significant Unmet Medical Need
Article content
Vascularized pinguecula affects millions of Americans and represents a substantial unmet medical need in ophthalmology. This common, benign conjunctival growth can become problematic when it develops abnormal blood vessels and inflammation, which can lead to persistent redness, irritation, pain, and foreign body sensation. Current management options are limited, with many patients relying on off-label corticosteroids or surgical excision, both of which carry significant limitations and potential complications.
Article content
Study Design and Results
Article content
The multicenter, randomized, double-masked, vehicle-controlled Phase 2 study 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. The primary endpoint was the change from baseline in conjunctival hyperemia at Day 28, as measured by an independent reading center using standardized digital imaging protocols.
Article content
'There is a significant unmet need for patients suffering from symptomatic pinguecula, as current therapies are largely off-label and may carry safety concerns with long-term use,' said Dr. John Hovanesian, Clinical Professor of Ophthalmology and recognized key opinion leader in anterior segment disease. 'The results from this trial are exciting, as they demonstrate that a targeted, non- steroidal therapy can meaningfully improve both the clinical signs and symptoms that impact patients' quality of life.'
Article content
'As a principal investigator in this study, I was impressed by the consistency and magnitude of improvement in both objective redness and patient-reported discomfort with CBT-004,' commented Dr. Sherif El-Harazi, Medical Director at Global Research Management. 'The safety profile was excellent, and I believe this therapy could represent a meaningful advance for our patients with vascularized pinguecula.'
Article content
About CBT-004
Article content
CBT-004 is a novel, preservative-free topical ophthalmic solution containing a potent and selective inhibitor of vascular endothelial growth factor (VEGF) receptors and platelet-derived growth factor (PDGF) receptors. The formulation is specifically designed to reduce abnormal blood vessel growth and inflammation associated with vascularized pinguecula while minimizing potential ocular surface toxicity through its preservative- free composition.
Article content
Next Steps and Regulatory Strategy
Article content
Based on these positive Phase 2 results, Cloudbreak Pharma Inc. plans to advance CBT-004 into Phase 3 development and initiate discussions with the U.S. Food and Drug Administration (FDA) to establish the regulatory pathway toward potential approval. The company anticipates providing updates on Phase 3 study design and timing in the coming months.
Article content
Market Opportunity
Article content
The vascularized pinguecula market represents a significant commercial opportunity with limited therapeutic options. The prevalence of pinguecula increases with age and UV exposure, affecting a substantial portion of the aging population. With no FDA-approved treatments specifically indicated for this condition, CBT-004 has the potential to become a category-defining therapy in this underserved market.
Article content
About Cloudbreak Pharma Inc.
Article content
Cloudbreak Pharma Inc. is a clinical-stage ophthalmology company dedicated to developing innovative therapies for ocular surface diseases with high unmet medical need. The company's pipeline focuses on novel treatments targeting inflammation, vascularization, and other pathological processes affecting the ocular surface. Cloudbreak is committed to improving outcomes for patients with challenging eye conditions through scientifically-driven therapeutic development.
Article content
Forward-Looking Statements
Article content
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the potential therapeutic benefits of CBT-004, the company's clinical development plans, regulatory strategy, and market opportunity. These forward-looking statements are based on current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Factors that could cause actual results to differ include, but are not limited to, the uncertainty of clinical trial results, regulatory approval processes, competitive developments, and other risks detailed in the company's filings. The company undertakes no obligation to update these forward-looking statements except as required by law.
Article content
Article content
Article content
Contacts
Article content
Contact Information:
Article content
Article content
Cloudbreak Pharma Inc.
Article content
Article content
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
National Post
3 hours ago
- National Post
Echo Responds to Misinformation with Science: Hydrogen Water Bottles Outperform Tablets in Safety, Efficacy, and Value
Article content SALT LAKE CITY — Echo, the global leader in hydrogen health technology, is responding forcefully to a wave of misinformation being spread by influencers with financial agendas. False claims that the Echo Flask causes heavy metals poisoning or stops working after six months are not only wrong—they're dangerous. Article content 'Hydrogen health is growing fast—and that growth has attracted a swarm of pseudo-scientific influencers using fear, not facts, to push products that pay them more money,' said Josh Carr, CEO of Echo. 'We're done letting those lies go unchallenged.' Article content At the center of the recent smear campaign are false allegations that Echo's hydrogen water bottle stops producing hydrogen after six months and may leach harmful metals. These claims are categorically false, unsupported by any lab data, and contradicted by third-party testing and thousands of happy customers. Article content The Echo Flask is engineered with platinum-coated electrodes, a proprietary proton exchange membrane, and a self-cleaning system—guaranteeing high-concentration hydrogen performance for over 10,000 uses. Echo backs every unit with a 5-year warranty and provides published test results verifying both hydrogen output and water purity. Article content 'These accusations aren't coming from scientists or doctors. They're coming from influencers who make more money when they scare people into buying hydrogen tablets,' Carr said. 'They claim our bottle causes 'heavy metals poisoning,' but produce no lab report, no data—just fear bait.' Article content Echo acknowledges that some low-end hydrogen bottles do degrade quickly—especially those built with cheap electrodes or mass-produced knockoff parts. But the Echo Flask is in a different class: medical-grade materials, clean hydrogen output, and durable construction backed by a decade of engineering. Article content In contrast, hydrogen tablets—often promoted as a better alternative—have major safety, quality, and cost issues. Many contain unregulated magnesium, along with heavy metals like lead, and begin to degrade rapidly the moment you open the package. Article content 'These tablet pushers mislead the public with confusing numbers and manipulated science,' Carr continued. 'They talk about 'high ppm levels' as if that means something useful—but hydrogen dosage is measured in milligrams, not parts per million. A high ppm in a tiny volume can mean a low actual dose. Consumers are literally paying more for less. It's dirty, expensive water with barely any usable hydrogen.' Article content Beyond misleading metrics, tablets are a recurring cost—often over $150/month to match the hydrogen levels the Echo Flask delivers for pennies per day. They're unstable, expensive, and fundamentally misrepresented. Article content 'We've tested these tablets. We've tested our bottles. We publish our data. And we stand behind our technology. That's the difference,' said Carr. 'People deserve truth—not hype.' Article content As the hydrogen wellness category continues to grow, Echo urges consumers to look past influencer theatrics and focus on science, transparency, and value. For third-party test results, hydrogen education, and Echo's full product lineup, visit Article content Article content Article content Article content
National Post
3 hours ago
- National Post
Bausch + Lomb Announces Publication of Phase 3 Data on LUMIFY® Preservative Free Redness Reliever Eye Drops
Article content Phase 3 data show Bausch + Lomb's LUMIFY Preservative Free eye drops are as safe and effective as the original LUMIFY in reducing ocular redness The multicenter study with 380 participants confirmed that LUMIFY Preservative Free eye drops are non-inferior in efficacy to the original LUMIFY and have a favorable safety profile, offering an effective preservative-free option for sensitive eyes LUMIFY delivers noticeable results in one minute, lasts up to eight hours and is the No. 1 doctor-recommended redness reliever brand; more info at Article content VAUGHAN, Ontario — Bausch + Lomb Corporation (NYSE/TSX: BLCO), a leading global eye health company dedicated to helping people see better to live better, today announced Ophthalmology and Therapy has published results from a phase 3 study which assessed the efficacy and safety of LUMIFY Preservative Free redness reliever eye drops compared to LUMIFY redness reliever eye drops for reducing ocular redness. Article content 'Since launching in 2018, LUMIFY has been the No. 1 doctor-recommended redness reliever brand, known for delivering noticeable results in one minute and lasting up to eight hours,' 1 said John Ferris, president, Consumer, Bausch + Lomb. 'This study demonstrates that our new LUMIFY Preservative Free eye drops reduce redness quickly and are just as safe and effective as the original LUMIFY, providing a needed option for patients with eye sensitivities.' Article content In the randomized, active-controlled, multicenter study, 380 participants with ocular redness received either LUMIFY Preservative Free or LUMIFY, administered as a single drop four times daily for four weeks. The primary objective was to demonstrate that LUMIFY Preservative Free is non-inferior to LUMIFY in reducing ocular redness. The primary efficacy endpoint was investigator-assessed ocular redness score at eight timepoints from five-minutes to 240-minutes after drop administration on day one. The secondary objective of the study was to compare the safety of LUMIFY Preservative Free and LUMIFY. Article content The study met its primary objective, confirming that LUMIFY Preservative Free is statistically non-inferior to LUMIFY in reducing ocular redness in adults. A day one analysis of all 11 time points (one minute to 480 minutes post-administration) further supported these findings; and additional secondary efficacy endpoint data from one minute, 360 minutes and 480 minutes post-administration demonstrated that LUMIFY Preservative Free performs similarly to LUMIFY. The overall safety profile of LUMIFY Preservative Free was favorable and comparable to LUMIFY, and the occurrence of ocular treatment-emergent adverse events was similar in both treatment groups. In this clinical trial, LUMIFY Preservative Free demonstrated to have a low incidence of side effects, like rebound redness and loss of efficacy over time, when used as directed. Article content 'The results show that LUMIFY Preservative Free is a well-tolerated alternative option for consumers with ocular redness who have sensitivities to preservatives or are at increased risk of ocular surface disease,' said Melissa Toyos, MD, and partner, Toyos Clinic, Nashville, TN. Article content About the LUMIFY Brand Article content The LUMIFY brand began in 2018 with the U.S. launch of LUMIFY redness reliever eye drops. Before LUMIFY, redness relievers relied on the same ingredients for decades and were associated with well-known side effects. LUMIFY and LUMIFY Preservative Free are the only over-the-counter redness relievers formulated with low-dose brimonidine tartrate 0.025% that selectively target eye redness and offer excellent results with a lower risk of rebound redness and loss of efficacy when used as directed. In 2023, Bausch + Lomb introduced LUMIFY EYE ILLUMINATIONS™, a line of specialty eye care products specifically developed for the sensitive area around the eyes. In June 2025, Bausch + Lomb launched LUMIFY Preservative Free eye drops in the U.S. For more information on the LUMIFY brand, visit Article content Bausch + Lomb is dedicated to protecting and enhancing the gift of sight for millions of people around the world – from birth through every phase of life. Its comprehensive portfolio of approximately 400 products includes contact lenses, lens care products, eye care products, ophthalmic pharmaceuticals, over-the-counter products and ophthalmic surgical devices and instruments. Founded in 1853, Bausch + Lomb has a significant global research and development, manufacturing and commercial footprint with approximately 13,500 employees and a presence in approximately 100 countries. Bausch + Lomb is headquartered in Vaughan, Ontario, with corporate offices in Bridgewater, New Jersey. For more information, visit Article content Facebook Article content , Article content Instagram Article content , Article content LinkedIn Article content , Article content X Article content and Article content YouTube Article content . Article content References Article content ©2025 Bausch + Lomb. Article content Article content Article content Article content Article content Article content Contacts Article content Media Contact: Article content Article content Kristy Marks Article content Article content Article content
CTV News
3 hours ago
- CTV News
UnitedHealth falls short of second quarter expectations and offers weak outlook for 2025
The logo for UnitedHealth Group appears above a trading post on the floor of the New York Stock Exchange, April 17, 2025. (AP Photo/Richard Drew, file) UnitedHealth delivered disappointing second-quarter earnings and went conservative with its 2025 forecast as soaring medical costs continue to swamp insurers. The health care giant said Tuesday expenses that have jumped beyond what it expected when it set coverage prices will continue to pressure its performance. But the company expects a return to earnings growth in 2026. UnitedHealth now expects adjusted earnings of at least $16 per share in 2025 after withdrawing its previous forecast in May. It had started 2025 with expectations of making up to $30 per share. For the full year, analysts forecast earnings of $20.64 per share, according to the data firm FactSet. UnitedHealth Group Inc. runs one of the nation's largest health insurance and pharmacy benefits management businesses. The Eden Prairie, Minnesota, company also operates a growing Optum business that provides care and technology support. In May, the company withdrew its 2025 forecast due to higher-than-expected medical costs, and CEO Andrew Witty departed the company abruptly. He was replaced by Chairman Stephen Hemsley, who was the UnitedHealth CEO for more than a decade until 2017. That came after the company took the rare step in April of cutting its forecast. That pushed UnitedHealth shares down $130 in its worst single-day performance in over 25 years. Hemsley promised in June that UnitedHealth would establish a 'prudent' 2025 earnings outlook when it detailed second-quarter results. He also said the company had underestimated care activity and cost trends, but improvements were being made. In the second quarter, UnitedHealth reported adjusted earnings of $4.08 per share on $111.6 billion in total revenue. Analysts expected earnings of $4.48 per share on $111.5 billion in revenue, according to FactSet. The company's profit fell 19% to $3.41 billion even as revenue rose 13%. Medical costs, the company's biggest operating expense, jumped 20% to $78.6 billion in the quarter. UnitedHealth is normally the first insurer to report earnings every quarter. But this summer, it followed competitors like Elevance Health Inc. and Centene Corp. that have lowered their annual forecasts and delivered disappointing results. Several insurers say they have been hit by medical costs that are growing faster than expected. Companies have seen a rise in expensive emergency rooms visits and growing prescription drug costs, especially from expensive cancer treatments and gene therapy. They've also seen a rise in behavioral health care, which includes the treatment of mental health conditions and substance use disorders. UnitedHealth shares slid about more than 3% to $272.30 before the opening bell Tuesday. That price topped $630 last November to reach a new all-time high. But the stock has mostly shed value since December, when UnitedHealthcare CEO Brian Thompson was fatally shot in midtown Manhattan on his way to the company's annual investor meeting. Shares are down 44% so far this year. The Dow Jones Industrial Average, of which UnitedHealth is a member, has climbed 5%. Tom Murphy, The Associated Press
