艾力雅®8mg(阿柏西普8mg)
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拜耳艾力雅8mg中国上市 引领nAMD治疗新纪元
Zheng Quan Ri Bao· 2025-11-07 15:34
Core Insights - Bayer's Eylea® 8mg (Aflibercept 8mg) was launched during the China International Import Expo, approved for treating neovascular age-related macular degeneration (nAMD) in May 2023, offering a more effective and longer-interval treatment option for patients [1][2] Group 1: Product Overview - Eylea® 8mg provides a treatment regimen starting with monthly injections for the first three months, which can then be extended to every four months based on clinical assessment [1] - The product aims to enhance treatment adherence and quality of life for nAMD patients, addressing unmet medical needs [1][2] Group 2: Clinical Validation - The clinical value of Eylea® 8mg was validated in the pivotal Phase III PULSAR study, showing comparable vision improvement with longer injection intervals compared to the 2mg dosage [2] - Eylea® 8mg demonstrated a faster and higher rate of fluid resolution during the loading phase, addressing the need for reduced injection frequency while maintaining vision benefits [2] Group 3: Market Context - nAMD is a progressive eye disease leading to irreversible vision loss, with the number of affected individuals in China projected to rise from 4.5 million in 2020 to 8.8 million by 2050 [1] - Without timely intervention, approximately 75.7% of nAMD patients may progress to legal blindness within three years, highlighting the urgent need for effective treatment solutions [1]
拜耳艾力雅®8mg中国上市 引领nAMD治疗新纪元
Zheng Quan Ri Bao Wang· 2025-11-07 13:46
Core Insights - Bayer's Eylea® 8mg (Aflibercept 8mg) was launched during the China International Import Expo, approved for treating neovascular age-related macular degeneration (nAMD) in May 2023, offering a more effective and longer treatment interval for patients [1][2] - The product aims to enhance patient compliance and quality of life by reducing the frequency of injections from monthly to potentially every four months based on clinical assessments [1][2] Group 1 - Eylea® 8mg provides a significant upgrade in dosage and formulation, demonstrating strong early efficacy and prolonged disease control, which alleviates the burden of frequent hospital visits for patients [1][2] - The prevalence of nAMD in China is projected to rise from 4.5 million in 2020 to 8.8 million by 2050, with a high risk of progression to legal blindness if not treated promptly [1] - Bayer emphasizes a patient-centered approach, continuously addressing unmet medical needs in the field of ophthalmology [1][2] Group 2 - Current clinical guidelines recommend anti-VEGF injections as the first-line treatment for nAMD, yet there are significant gaps in disease control and treatment adherence due to short drug efficacy and high injection frequency [2] - The clinical value of Eylea® 8mg has been validated in the pivotal Phase III PULSAR study, showing comparable vision improvement with fewer injections compared to the 2mg dosage [2] - Eylea® 8mg has already commenced patient injections in several provinces in China, with expectations for broader patient access to this innovative treatment [2]