Core Viewpoint - The company has initiated a Phase IIa clinical trial for its innovative ophthalmic drug GPN00884, aimed at slowing the progression of myopia in children, marking a significant milestone in its ophthalmology segment [1][2] Group 1: Clinical Trial Details - The Phase IIa clinical trial is a randomized, double-blind, placebo-controlled study that plans to enroll over 80 participants aged 6 to 12 years [1] - The primary objective is to evaluate the efficacy and safety of GPN00884 eye drops in delaying myopia progression in children [1] Group 2: Product Characteristics - GPN00884 eye drops feature a novel mechanism of action and do not cause pupil dilation, light sensitivity, or accommodation reduction, which enhances patient compliance [1] - There is currently a lack of effective and safe medications for delaying myopia progression in children in the domestic market, indicating an unmet clinical need [1] Group 3: Previous Research Milestones - GPN00884 eye drops were previously approved for Phase I clinical research in March 2024, with all participants enrolled by August of the same year [2] - The Phase I results demonstrated good safety and tolerability in healthy subjects, with linear pharmacokinetic characteristics [2]
远大医药(00512)：全球创新眼科药物GPN00884在中国开展的IIa期临床研究完成了首例患者入组