Latest news with #eyedrops
Yahoo
3 days ago
- 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
Globe and Mail
11-07-2025
- Business
- Globe and Mail
Refresh Releases First of its Kind Eye Drop for Dry Eyes
MONTREAL, July 11, 2025 /CNW/ - AbbVie (NYSE: ABBV), announced today the availability of Refresh Advanced OMEGA-3 Lubricant Eye Drops in Canada. The new, preservative-free eye drop is designed to provide rapid and long-lasting relief from dry eyes with the inclusion of natural omega-3 oil that helps lock in moisture.
The Sun
07-07-2025
- Health
- The Sun
Eye drops used as hayfever remedy urgently recalled over risk of severe infection
BRITS have been warned eyedrops used as a hayfever remedy have been recalled over risk of serious infection. Retailers have been advised to "stop supplying" the affected batch "immediately". Potential side effects include a number of eye infections, including conjunctivitis, keratitis, and/or blepharitis, or, for susceptible patients, could be a more severe infection. A spokesperson from Medicines and Healthcare products Regulatory Agency said: "Class 2 Medicines Recall: Zaditen 0.25 mg/ml, eye drops, solution, Laboratoires Théa EL(25)A/34. "Laboratoires Théa trading as Thea Pharmaceuticals Limited have notified the MHRA of an out of specification event related to environmental monitoring during manufacturing, which may increase the risk of microbial contamination of the medicinal product. "As a precautionary measure the specific batch mentioned in this notification is being recalled. "To date, Thea Pharmaceuticals Limited have not received any reports of adverse incidents or product quality complaints related to this potential defect." The affected batch are number 4V64, with the expiry date September 30, 2026. The pack size is 5ml, and they were first distributed on January 27 this year. All stock must also be quarantined, and returned to the supplier, using the approved process. Thea Pharmaceuticals confirmed 11,360 packs of this batch were released and distributed. There have been no reported adverse events or product quality complaints received to date. And, no further action is required by patients as this is a Pharmacy and Wholesaler level recall. The spokesperson added: "Whilst the recall is precautionary and no adverse events have been reported by Thea Pharmaceuticals Limited, if any side effects were to be observed, these would be related to ocular infection and may include conjunctivitis, keratitis, and/or blepharitis, or, for susceptible patients, could be a more severe infection. "Patients who experience adverse reactions or have any questions about the medication should seek medical attention. "Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme." Your product recall rights Chief consumer reporter James Flanders reveals all you need to know. Product recalls are an important means of protecting consumers from dangerous goods. As a general rule, if a recall involves a branded product, the manufacturer would usually have lead responsibility for the recall action. But it's often left up to supermarkets to notify customers when products could put them at risk. If you are concerned about the safety of a product you own, always check the manufacturer's website to see if a safety notice has been issued. When it comes to appliances, rather than just food items, the onus is usually on you - the customer - to register the appliance with the manufacturer as if you don't there is no way of contacting you to tell you about a fault. If you become aware that an item you own has been recalled or has any safety noticed issued against it, make sure you follow the instructions given to you by the manufacturer. They should usually provide you with more information and a contact number on its safety notice. In some cases, the manufacturer might ask you to return the item for a full refund or arrange for the faulty product to be collected. You should not be charged for any recall work - such as a repair, replacement or collection of the recalled item 1 is your go-to destination for the best celebrity news, real-life stories, jaw-dropping pictures and must-see video.
Daily Mail
07-07-2025
- Health
- Daily Mail
BREAKING NEWS Urgent warning issued as drug chiefs recall common eye drops due to risk they could cause BLINDNESS
Health officials have urgently recalled over 11,000 eye drops due to manufacturing issues that may have made the products unsterile that could leave patients blind. UK medicines watchdog the Medicines and Healthcare Products Regulatory Agency (MHRA) slapped an alert on one batch of Zaditen 0.25mg/ml eye drops, used to treat seasonal allergies such as hay fever. It is feared the drug may have been contaminated during manufacturing, causing side effects including conjunctivitis and inflammation of the cornea and eyelid. Left untreated, these conditions can cause permanent eye damage and even blindness. But the MHRA, which published the alert today, said it had not yet received any complication or reports of harm from patients who had taken the commonly-prescribed eye drops. The recall only impacts one batch of the 5ml eye drop solution, manufactured by Laboratoires Théa, with the batch number 4V64 and an expiry date of September 30 2026.
Medscape
25-06-2025
- Health
- Medscape
Omidenepag Promising Against Glaucoma in Real-World Study
TOPLINE: The daily use of eye drops containing 0.002% omidenepag isopropyl reduced intraocular pressure and was well‐tolerated in patients newly diagnosed with primary open‐angle glaucoma who had not previously received topical ophthalmic treatment. METHODOLOGY: Researchers conducted a phase 4 clinical trial at four eye centers in Korea to evaluate the effectiveness and safety of the drops in patients newly diagnosed with primary open-angle glaucoma. Participants in the study had defects in their field of vision, had not previously received treatment for glaucoma, and had an intraocular pressure of 10-34 mm Hg; those with an intraocular pressure of ≤ 21 mm Hg were classified as having normal tension glaucoma. Participants (N = 50) received one drop of 0.002% omidenepag isopropyl ophthalmic solution each evening for 12 weeks; adherence to the medication was assessed at weeks 4 and 12. The primary endpoint of the trial was the change in intraocular pressure from baseline to week 12. TAKEAWAY: Among the enrolled participants, the effectiveness of omidenepag isopropyl eye drops was evaluated in the 37 patients who achieved at least 70% adherence to the medication, while safety was assessed in all 50 participants. The mean intraocular pressure decreased significantly from 16.19 mm Hg at baseline to 13.55 mm Hg at week 12 (P < .0001), representing a 16% reduction; in the subgroup of patients with normal tension glaucoma, the mean intraocular pressure reduced from 15.79 mm Hg at baseline to 13.27 mm Hg at week 12. The medication effectively reduced the mean intraocular pressure as early as week 4 (P < .0001). The most common adverse events were hyperemia (13 cases) and iridocyclitis (5 cases), with no systemic reactions reported. IN PRACTICE: 'Omidenepag isopropyl 0.002% ophthalmic solution had a rapid IOP-lowering effect as the percentage reduction from baseline was 15% at week 4,' the researchers wrote. 'Omidenepag isopropyl 0.002% ophthalmic solution is suitable for first-line use at first diagnosis' of primary open-angle glaucoma, including in patients with normal tension glaucoma, they added. SOURCE: This study was led by Hyoung Won Bae, MD, PhD, of the Yonsei University Severance Hospital in Seoul, Korea. It was published online on June 17, 2025, in the Journal of Glaucoma. LIMITATIONS: This study lacked a control group and may have been subject to biases, as is common in observational studies. It also enrolled fewer participants than planned. DISCLOSURES: This study received funding from Santen Pharmaceutical Co., Ltd. All authors disclosed receiving honoraria from Santen. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
