Latest news with #eyedrop
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
The Sun
11-06-2025
- Entertainment
- The Sun
Molly-Mae's sister Zoe has horrific airport spat with savage man who mocked droopy Botox eye she's STILL struggling with
EYE DRAMA The 28-year-old said she hasn't ruled out getting Botox again, but will probably wait "a few years" MOLLY-MAE Hague's sister Zoe has opened up about a horrific airport spat she had with a traveller who mocked her droopy eye. The 28-year-old was left with the droop after getting Botox - the second time she's had the same unfortunate results in less than a year. 7 7 7 She's since been wearing sunglasses as much as possible, but removed them to share an "eye update" in her latest YouTube video. Lifting the glasses, Zoe sighed: "It looks a lot worse on camera. "I don't know if that's just because I'm so used to it now. "I'm like, 'Is this my face?' "It's not been good. It's been causing me a lot of upset but equally I'm just like, thank goodness it's sunglasses season!" Zoe went on to recall a recent "really upsetting" incident that happened during a trip to Portugal with her friend Fern. "Just as we landed in Portugal, there was a queue going behind me and a horrible woman - I don't know if she was drunk, she must have been - was trying to get past me. "She's like, 'Why you just stood there like a d**khead? "And I was said, 'Why did you just call me that?'" Then her husband came over, at which point there was a "bit of back and forth" between him and Zoe about what had actually happened, and who was in the wrong. "He looks at me and goes 'Sort you daft eye out, you c***'," she continued. Zoe sarcastically said that it was "just what I need as I've tried to escape the situation". "I could have got angry, I could have got upset but yeah fair enough, I couldn't agree more!" she added. "But also just like, really just kick me when I'm down, you know? "At least let the dust settle - give it another week and then maybe chuck some insults at me!" Zoe added that she and her pal decided to "make a joke of it", because "otherwise it wouldn't have been a good start to the trip". Dr. Aamer Khan reveals the do's and don'ts with Botox Do's Before Botox Consult a qualified practitioner with medical training and experience. Inform your practitioner about all medications, supplements, and medical conditions. Avoid alcohol and blood-thinning medications (aspirin, ibuprofen, vitamin E) for 24–48 hours. Stay hydrated and have a light meal before your appointment. Ask questions about the procedure, expectations, and outcomes. Don'ts Before Botox Avoid retinol, glycolic acid, or exfoliants on treatment areas for 24 hours. Don't schedule within 2 weeks of major events to allow time for the treatment to work and any healing. needed, possible bruising, which can occur. Reschedule if you're feeling unwell (cold, infection, etc.). Try to avoid makeup on the day of treatment, unless it is mineral make up. Do's After Botox Gently move treated muscles (smile, frown) to help Botox settle. Stay upright for 4–6 hours post-treatment. Apply cold compresses gently to reduce swelling if there is any. Use mild, non-active skincare to keep skin clean and calm. Don'ts After Botox Do not lie down or bend over for at least 4–6 hours. Avoid touching or rubbing the injected area for 24 hours. Skip workouts and heat exposure (gym, saunas, hot yoga) for 24 hours. Don't apply makeup or active skincare for at least 12–24 hours. Avoid alcohol and blood thinners for 24 hours post-treatment. For any concerns post-treatment, always contact your provider directly. Mild redness, swelling, or bruising is common and usually subsides within a few days. However, she also added of her eye: "I know it's temporary and it will go so it's just an inconvenience really!" Zoe was also asked if she would get Botox again, and revealed that if she did, it "wouldn't be for a few years" and she would "go somewhere else". "No offense to the lady I was seeing but obviously something just wasn't working out there. "No bad blood there - she's great, we really got on well. "Like I say, she did me for the wedding, and thank God it didn't happen for the wedding. "I'd have had to change the date of the wedding!" 7 7 7
