拨康视云锚定创新疗法，CBT-004点亮血管化睑裂斑治疗新曙光

Core Insights - The second phase clinical trial of CBT-004 eye solution by Bokan Vision Pharmaceutical Co., Ltd. (2592.HK) has yielded positive results, indicating its potential to fill a treatment gap for vascularized conjunctival lesions [1][3] - The trial demonstrated significant improvement in conjunctival hyperemia and relief of five common ocular symptoms, with no adverse events reported, confirming the safety of the treatment [1][2] Group 1: Clinical Trial Results - The trial included 88 adult patients with vascularized conjunctival lesions, who were randomly assigned to two treatment groups or a placebo group [1] - The primary endpoint was achieved, showing statistically significant improvement in conjunctival hyperemia at day 28 for both concentrations of CBT-004 compared to the placebo [1][2] - Rapid onset of action was observed, with significant improvement noted as early as day 7, and benefits sustained throughout the 28-day treatment period [2] Group 2: Expert Opinions - Renowned ophthalmologist Dr. John Hovanesian highlighted the significant treatment gap for symptomatic conjunctival lesions and praised the trial results as encouraging for a targeted non-steroidal therapy [3] - Dr. Sherif El-Harazi, Medical Director at Global Research Management, expressed being impressed by CBT-004's sustained and significant improvements in both objective and subjective symptoms, emphasizing its excellent safety profile [3] Group 3: Market Potential - Vascularized conjunctival lesions affect millions globally, particularly among the elderly, representing a significant unmet medical need in ophthalmology [4] - Current treatment options are limited, often relying on off-label use of corticosteroids or surgical removal, highlighting the urgent need for a safe and effective approved therapy [4] - CBT-004's unique mechanism and promising phase II data position it as a potential first-in-class or best-in-class therapy in a market with substantial unmet commercial potential [8] Group 4: Future Development Plans - Following the positive phase II results, the company plans to expedite CBT-004 into the critical phase III clinical trial stage [7] - The company has initiated communication with the FDA to optimize the registration approval pathway, with updates on the phase III trial design and timeline expected in the coming months [7] Group 5: Innovative Therapy Design - CBT-004 is a preservative-free topical eye drop designed to target the core pathological mechanisms of vascularized conjunctival lesions, specifically abnormal angiogenesis and inflammatory responses [6] - Its formulation includes a potent and selective inhibitor of vascular endothelial growth factor (VEGF) and platelet-derived growth factor (PDGF) receptors, minimizing potential ocular toxicity and enhancing long-term safety [6]