{"id":40294,"date":"2025-08-28T15:11:21","date_gmt":"2025-08-28T07:11:21","guid":{"rendered":"https:\/\/flcube.com\/?p=40294"},"modified":"2025-08-28T15:11:22","modified_gmt":"2025-08-28T07:11:22","slug":"santen-receives-boao-lecheng-approval-for-ryjusea-a-preservative%e2%80%91free-atropine-eye-drop-for-pediatric-myopia","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=40294","title":{"rendered":"Santen Receives Boao Lecheng Approval for RYJUSEA \u2013 A Preservative\u2011Free Atropine Eye Drop for Pediatric Myopia"},"content":{"rendered":"\n<p>Japan\u2011based <strong>Santen Pharmaceutical Co., Ltd.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/quote\/4536:TYO\">TYO: 4536<\/a>) announced that its <strong>RYJUSEA<\/strong> (atropine sulfate hydrate) has received marketing approval from the <strong>Boao Lecheng Pilot Zone<\/strong> for the treatment of myopia in children and adolescents.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-product-overview\">Product Overview<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Active Ingredient<\/strong> \u2013 <strong>Atropine sulfate<\/strong> (0.05\u202f% w\/v)<\/li>\n\n\n\n<li><strong>Formulation<\/strong> \u2013 <strong>Preservative\u2011free<\/strong> to minimise ocular irritation and ensure long\u2011term safety in pediatric patients<\/li>\n\n\n\n<li><strong>Mechanism<\/strong> \u2013 Inhibits axial elongation of the eye, thereby slowing progression of myopia<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-clinical-evidence\">Clinical Evidence<\/h3>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Parameter<\/th><th>RYJUSEA<\/th><th>Placebo<\/th><th>P\u2011value<\/th><\/tr><\/thead><tbody><tr><td><strong>Spherical Equivalent Refraction (24\u202fmo)<\/strong><\/td><td>\u20131.006\u202fD<\/td><td>\u20131.643\u202fD<\/td><td>&lt;0.0001<\/td><\/tr><tr><td><strong>Axial Elongation (24\u202fmo)<\/strong><\/td><td>0.51\u202fmm<\/td><td>0.74\u202fmm<\/td><td>&lt;0.0001<\/td><\/tr><tr><td><strong>Spherical Equivalent Refraction (36\u202fmo)<\/strong><\/td><td>Sustained benefit<\/td><td>\u2013<\/td><td>\u2013<\/td><\/tr><tr><td><strong>Axial Elongation (36\u202fmo)<\/strong><\/td><td>Sustained benefit<\/td><td>\u2013<\/td><td>\u2013<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>Phase\u202f2\/3 studies demonstrated that RYJUSEA significantly outperformed placebo in controlling both spherical equivalent refraction and axial elongation. The therapeutic effect persisted throughout the 36\u2011month treatment period, with no unanticipated safety concerns identified.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-regulatory-milestone\">Regulatory Milestone<\/h3>\n\n\n\n<p>The Boao Lecheng Pilot Zone approval positions RYJUSEA for commercial launch across mainland China, Hong\u202fKong, Macau and Taiwan, providing a new, evidence\u2011based option for clinicians treating pediatric myopia.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\" id=\"h-market-implications\">Market Implications<\/h3>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Growing Demand<\/strong> \u2013 Rising prevalence of myopia in East Asia and increasing parental awareness create a sizable market opportunity.<\/li>\n\n\n\n<li><strong>Competitive Edge<\/strong> \u2013 Preservative\u2011free formulation and robust clinical data differentiate RYJUSEA from existing atropine products.<\/li>\n\n\n\n<li><strong>Strategic Growth<\/strong> \u2013 The approval aligns with Santen\u2019s broader expansion strategy in ophthalmic therapeutics.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Japan\u2011based Santen Pharmaceutical Co., Ltd. (TYO: 4536) announced that its RYJUSEA (atropine sulfate hydrate) has&#8230;<\/p>\n","protected":false},"author":1,"featured_media":40295,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[91,44,15,2079],"class_list":["post-40294","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-boao-lecheng-pilot-zone","tag-ophthalmology","tag-product-approvals","tag-tyo-4536"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Santen Receives Boao Lecheng Approval for RYJUSEA \u2013 A Preservative\u2011Free Atropine Eye Drop for Pediatric Myopia - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Japan\u2019s Santen Pharmaceutical Co., Ltd. has secured marketing approval from the Boao Lecheng Pilot Zone for RYJUSEA, a preservative\u2011free atropine sulfate eye drop that slows myopia progression in children and adolescents. 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