Core Viewpoint - The approval of 0.02% and 0.04% atropine eye drops marks a significant milestone in the prevention and control of myopia among children and adolescents in China, transitioning from a "single concentration" approach to a "stair-step concentration" model, enabling personalized and precise interventions [1][3][6] Group 1: Market Context - The overall myopia rate among children and adolescents in China is 51.9%, showing a slight decrease from 2021, but the situation remains severe with a high prevalence of early-onset and severe cases [2] - The introduction of varying concentrations of atropine eye drops responds to the clinical need for tailored solutions, particularly for high-risk children who may not benefit from a single concentration [2][7] Group 2: Product Development - The newly approved eye drops underwent rigorous randomized double-blind clinical trials, demonstrating their effectiveness and safety in delaying the progression of myopia in children [3][4] - The clinical study involved 800 participants across 28 centers, with a treatment duration of 2 years and a 1-year observation period post-treatment, confirming the efficacy of the new concentrations compared to a placebo [4] Group 3: Company Profile - Shenyang Xingqi Eye Medicine Co., Ltd. has been a pioneer in the research and development of atropine eye drops for myopia control, initiating its low-concentration atropine project in 2014 and collaborating with Singapore's National Eye Centre in 2016 [5] - The company has developed a comprehensive management drug covering different stages of myopia progression, showcasing its innovative capabilities in the ophthalmic pharmaceutical field [5] Group 4: Health Policy Alignment - The approval of these new concentrations aligns with the "Healthy China 2030" initiative, enhancing the drug treatment system for myopia prevention and providing robust support for achieving national health goals [6]
告别防控“一刀切”:兴齐眼药0.02%、0.04%阿托品获批,孩子近视方案能“量体裁衣”了