Latest news with #preservativefree
National Post
a day ago
- Health
- 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
Yahoo
21-07-2025
- Health
- Yahoo
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 IRVINE, Calif., July 21, 2025--(BUSINESS WIRE)--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. Key Phase 2 Results Primary Endpoint Achieved: 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. Rapid Onset and Sustained Efficacy: 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. Significant Symptom Relief: 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. Excellent Safety Profile: 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. Addressing a Significant Unmet Medical Need 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. Study Design and Results 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. Expert Commentary "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." "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." About CBT-004 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. Next Steps and Regulatory Strategy 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. Market Opportunity 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. About Cloudbreak Pharma Inc. 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. Forward-Looking Statements 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. Please note that the information contained in this press release may not be complete. For further details about Cloudbreak Pharma Inc., and our drug candidates, please refer to our company's website (at View source version on Contacts Contact Information: Cloudbreak Pharma media@ Web: Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
National Post
21-07-2025
- Health
- National Post
Cloudbreak Pharma Inc. Announces Positive Phase 2 Results for CBT-004 in Patients with Vascularized Pinguecula
Article content 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
