{"id":5850,"date":"2024-10-31T16:10:24","date_gmt":"2024-10-31T21:10:24","guid":{"rendered":"https:\/\/nanostherapeutics.com\/?p=5850"},"modified":"2025-06-27T11:07:05","modified_gmt":"2025-06-27T16:07:05","slug":"nanoscope-presented-positive-2-year-randomized-controlled-trial-results-of-mco-010-for-retinitis-pigmentosa","status":"publish","type":"post","link":"https:\/\/nanostherapeutics.com\/ja\/2024\/10\/31\/nanoscope-presented-positive-2-year-randomized-controlled-trial-results-of-mco-010-for-retinitis-pigmentosa\/","title":{"rendered":"\u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u793e\u3001\u7db2\u819c\u8272\u7d20\u5909\u6027\u75c7\u306b\u5bfe\u3059\u308bMCO-010\u306e2\u5e74\u9593\u306e\u30e9\u30f3\u30c0\u30e0\u5316\u6bd4\u8f03\u8a66\u9a13\u3067\u826f\u597d\u306a\u7d50\u679c\u3092\u767a\u8868"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"5850\" class=\"elementor elementor-5850\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-54ac0541 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"54ac0541\" data-element_type=\"section\" data-e-type=\"section\">\r\n\t\t\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\r\n\t\t\t\t\r\n\t\t\t\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-367865ba\" data-id=\"367865ba\" data-element_type=\"column\" data-e-type=\"column\">\r\n\r\n\t\t\t\t\r\n\t\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\r\n\t\t\t\t\t\t\t\t\t\t\r\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-45ffa5a0 elementor-widget elementor-widget-text-editor\" data-id=\"45ffa5a0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\tDALLAS-Oct. 31, 2024 &#8212; Nanoscope Therapeutics, Inc., a BLA filing-stage biotechnology company developing gene therapies for retinal degenerative diseases, today announced that positive 2-year results from the Phase\u00a02b\u00a0RESTORE randomized, controlled clinical trial (RCT) of its lead program, MCO-010,\u00a0a mutation-agnostic gene therapy for patients with permanent and severe vision loss from advanced retinitis pigmentosa (RP) were presented by\u00a0Allen C. Ho, MD, FACS, FASRS, Director of Retina Research and Co-Director of the Retina Service at Wills Eye Hospital, and Chief Medical Advisor of Nanoscope, on\u00a0October 20, 2024 at the recently concluded\u00a0AAO 2024 Annual Meeting.\n\nDuring his presentation titled &#8220;Efficacy and Safety of MCO-010 Optogenetic Therapy for Vision Restoration in Patients With Severe Vision Loss Due to RP: Two-Year TOPLINE Results From a Phase\u00a0<span class=\"xn-money\">2b<\/span>\u300c3 \u30e9\u30f3\u30c0\u30e0\u5316\u507d\u624b\u8853\u5bfe\u7167\u81e8\u5e8a\u8a66\u9a13 (RESTORE)\u300d\u3067\u3001\u30db\u30fc\u535a\u58eb\u306f\u3001\u507d\u624b\u8853\u5bfe\u7167\u8a66\u9a13\u306e\u904e\u7a0b\u3092\u901a\u3058\u3066\u5f8c\u306e\u6642\u70b9\u3067\u7dad\u6301\u3055\u308c\u305f\u5e73\u5747\u77ef\u6b63\u8996\u529b (BCVA) \u306e\u6539\u5584\u304c LogMAR (3 \u884c 15 \u6587\u5b57\u76f8\u5f53) \u3067\u7d04 0.3 \u3068\u6e2c\u5b9a\u3055\u308c\u305f\u3068\u3044\u3046\u5229\u70b9\u3092\u5f37\u8abf\u3057\u307e\u3057\u305f\u3002\u305d\u306e\u4ed6\u306e\u77e5\u898b\u306b\u306f\u4ee5\u4e0b\u304c\u542b\u307e\u308c\u307e\u3059\u3002\n<ul type=\"disc\">\n \t<li>\u9ad8\u7528\u91cfMCO-010\u7fa4\u3067\u306f\u300152\u9031\u76ee\uff08\u4e3b\u8981\u8a55\u4fa1\u9805\u76ee\uff09\u306876\u9031\u76ee\uff08\u4e3b\u8981\u526f\u6b21\u8a55\u4fa1\u9805\u76ee\uff09\u3067\u305d\u308c\u305e\u308c0.337 \u00b1 0.0829\u30680.539 \u00b1 0.1032 LogMAR\uff08\u5bfe\u7167\u7fa4\u306b\u5bfe\u3057\u3066\u3001p = 0.0209\u30680.0014\uff09\u306e\u5e73\u5747\u6539\u5584\u304c\u898b\u3089\u308c\u3001\u4f4e\u7528\u91cfMCO-010\u7fa4\u3067\u306f\u3001\u540c\u3058\u6642\u70b9\u3067\u305d\u308c\u305e\u308c0.382 \u00b1 0.1244\u30680.374 \u00b1 0.1332 LogMAR\uff08\u5bfe\u7167\u7fa4\u306b\u5bfe\u3057\u3066\u3001p = 0.0290\u30680.0652\uff09\u306e\u5e73\u5747\u6539\u5584\u304c\u898b\u3089\u308c\u307e\u3057\u305f\uff08<a href=\"https:\/\/nanostherapeutics.com\/ja\/2024\/03\/26\/nanoscope-therapeutics-announces-top-line-results-from-ph2-trial-of-mco-010-for-retinitis-pigmentosa\/\" target=\"_blank\" rel=\"nofollow noopener\">\u4ee5\u524d\u306b\u767a\u8868\u3055\u308c\u305f<\/a>).<\/li>\n \t<li>52\u9031\u76ee\u306b\u3001MCO-010\u3092\u6295\u4e0e\u3055\u308c\u305f18\u4eba\u4e2d7\u4eba\uff0839%\uff09\u306fBCVA\u6539\u5584\u304c0.3 LogMAR\u4ee5\u4e0a\u3092\u793a\u3057\u300118\u4eba\u4e2d10\u4eba\uff0856%\uff09\u306f76\u9031\u76ee\u306b\u3053\u306e\u95be\u5024\u306b\u9054\u3057\u307e\u3057\u305f\u3002<\/li>\n \t<li>\u7e26\u65ad\u7684\u5206\u6790\u3067\u306f\u300136 \u9031\u76ee\u304b\u3089 88 \u9031\u76ee\u306e\u8a3a\u5bdf\u3067\u3001\u6a21\u64ec\u5bfe\u7167\u3068\u6bd4\u8f03\u3057\u3066\u7d71\u8a08\u7684\u306b\u6709\u610f\u306a\u5e73\u5747 BCVA \u6539\u5584\u304c\u793a\u3055\u308c\u307e\u3057\u305f\u3002<\/li>\n \t<li>52 \u9031\u76ee\u300176 \u9031\u76ee\u3001100 \u9031\u76ee\u307e\u3067\u306e BCVA \u66f2\u7dda\u4e0b\u9762\u7a4d\u30d7\u30ed\u30d5\u30a1\u30a4\u30eb\u306f\u3001MCO-010 \u306e\u4e21\u6295\u4e0e\u7fa4\u3067\u6a21\u64ec\u5bfe\u7167\u7fa4\u3068\u6bd4\u8f03\u3057\u3066 5 \u500d\u5927\u304d\u304f\u3001\u7d71\u8a08\u7684\u306b\u6709\u610f\u3067\u3057\u305f\u3002<\/li>\n \t<li>MCO-010 \u306f\u5fcd\u5bb9\u6027\u304c\u826f\u597d\u3067\u3001MCO-010 \u30b0\u30eb\u30fc\u30d7\u3067\u306f\u91cd\u7be4\u306a\u6709\u5bb3\u4e8b\u8c61\u306f\u5831\u544a\u3055\u308c\u3066\u3044\u307e\u305b\u3093\u3002\u6700\u3082\u591a\u304f\u5831\u544a\u3055\u308c\u305f\u6709\u5bb3\u4e8b\u8c61\u306f\u3001\u524d\u623f\u7d30\u80de (44% MCO-010\u300122% \u6a21\u64ec\u5bfe\u7167) \u3068\u773c\u5727\u4ea2\u9032 (39% MCO-010\u300111% \u6a21\u64ec\u5bfe\u7167) \u3067\u3057\u305f\u3002\u3053\u308c\u3089\u306e\u6709\u5bb3\u4e8b\u8c61\u306f\u3001\u5c40\u6240\u85ac\u3067\u89e3\u6d88\u307e\u305f\u306f\u6291\u5236\u3055\u308c\u307e\u3057\u305f\u3002<\/li>\n<\/ul>\n&#8220;The durable statistically significant vision improvement achieved at multiple time points during the 2-year study is highly noteworthy. This degree of improvement has never been observed in a randomized, controlled trial of a highly heterogeneous severe vision-loss patient population,&#8221; said Dr. Ho. &#8220;These findings deliver hope to patients and ophthalmologists that a solution is close to being found. We are finally on the brink of an impactful in-office, mutation-agnostic gene therapy for people with severe vision loss.&#8221;\n\nRESTORE is the first-ever RCT to show statistically significant visual acuity improvement in the RP patient population and a key part of the upcoming BLA submission planned for Nanoscope&#8217;s RP program. The RESTORE study design has been\u00a0<a href=\"https:\/\/nanostherapeutics.com\/ja\/2024\/03\/26\/nanoscope-therapeutics-announces-top-line-results-from-ph2-trial-of-mco-010-for-retinitis-pigmentosa\/\" target=\"_blank\" rel=\"nofollow noopener\">\u4ee5\u524d\u306b\u767a\u8868\u3055\u308c\u305f<\/a>.\n\n&#8220;Nanoscope is proud to be a leader in the optogenetic space, advancing a mutation and disease agnostic therapy designed for optimal performance with rapid kinetics and sensitivity across the visible light spectrum and at ambient light levels,&#8221; said\u00a0Sulagna Bhattacharya, co-founder, and Chief Executive Officer of Nanoscope. &#8220;We recognize the high unmet need, and we are working diligently to bring MCO-010 to these patients with permanent and progressive vision loss from retinal degeneration. They are our North Star.&#8221;\n\n<b>\u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u30fb\u30bb\u30e9\u30d4\u30e5\u30fc\u30c6\u30a3\u30af\u30b9\u793e\u306b\u3064\u3044\u3066<br class=\"dnr\" \/><\/b>\u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u30fb\u30bb\u30e9\u30d4\u30e5\u30fc\u30c6\u30a3\u30af\u30b9\u306f\u3001\u6cbb\u7642\u6cd5\u306e\u306a\u3044\u7db2\u819c\u5909\u6027\u75be\u60a3\u3067\u5931\u660e\u3057\u305f\u4f55\u767e\u4e07\u4eba\u3082\u306e\u60a3\u8005\u306e\u305f\u3081\u306b\u3001\u907a\u4f1d\u5b50\u306b\u4f9d\u5b58\u3057\u306a\u3044\u8996\u529b\u56de\u5fa9\u306e\u305f\u3081\u306e\u30aa\u30d7\u30c8\u30b8\u30a7\u30cd\u30c6\u30a3\u30c3\u30af\u7642\u6cd5\u3092\u958b\u767a\u3057\u3066\u3044\u308b\u3002\u540c\u793e\u306e\u4e3b\u529b\u88fd\u54c1\u3067\u3042\u308bMCO-010\u306f\u3001\u7db2\u819c\u8272\u7d20\u5909\u6027\u75c7\uff08<a href=\"https:\/\/clinicaltrials.gov\/study\/NCT05417126\" target=\"_blank\" rel=\"nofollow noopener\">NCT04945772<\/a>\u540c\u793e\u306f\u3001\u30b9\u30bf\u30fc\u30ac\u30eb\u30c8\u75c5\u60a3\u8005\u3092\u5bfe\u8c61\u3068\u3057\u305fMCO-010\u7642\u6cd5\u306e\u7b2c2\u76f8STARLIGHT\u8a66\u9a13\u3092\u5b8c\u4e86\u3057\u305f\uff08<a href=\"https:\/\/clinicaltrials.gov\/study\/NCT04945772\" target=\"_blank\" rel=\"nofollow noopener\">NCT05417126<\/a>\uff09\u305d\u3057\u3066\u6700\u8fd1\u00a0<a href=\"https:\/\/www.prnewswire.com\/news-releases\/nanoscope-therapeutics-announces-end-of-phase-2-meeting-with-us-fda-and-plan-to-initiate-a-phase-3-clinical-trial-of-mco-010-to-treat-stargardt-macular-degeneration-302247017.html\" target=\"_blank\" rel=\"nofollow noopener\">\u7b2c3\u30d5\u30a7\u30fc\u30ba\u3092\u958b\u59cb\u3059\u308b\u8a08\u753b\u3092\u767a\u8868\u3057\u305f<\/a>\u00a02025\u5e74\u7b2c1\u56db\u534a\u671f\u306b\u767b\u9332\u8a66\u9a13\u3092\u5b9f\u65bd\u3057\u307e\u3059\u3002MCO-010\u306f\u3001RP\u3068Stargardt\u306e\u4e21\u65b9\u3067FDA\u30d5\u30a1\u30b9\u30c8\u30c8\u30e9\u30c3\u30af\u6307\u5b9a\u3068FDA\u5e0c\u5c11\u75be\u75c5\u7528\u533b\u85ac\u54c1\u6307\u5b9a\u3092\u53d7\u3051\u3066\u3044\u307e\u3059\u3002\u524d\u81e8\u5e8a\u8cc7\u7523\u306b\u306f\u3001\u5730\u56f3\u72b6\u840e\u7e2e\u306b\u5bfe\u3059\u308b\u975e\u30a6\u30a4\u30eb\u30b9\u6027\u30ec\u30fc\u30b6\u30fc\u9001\u9054MCO-020\u907a\u4f1d\u5b50\u6cbb\u7642\u304c\u542b\u307e\u308c\u307e\u3059\u3002\n\n<b>\u6295\u8cc7\u5bb6\u9023\u7d61\u5148:<\/b><br class=\"dnr\" \/>\u30a2\u30eb\u30b4\u30c3\u30c8\u30d1\u30fc\u30c8\u30ca\u30fc\u30ba<br class=\"dnr\" \/>212-600-1902<br class=\"dnr\" \/><a href=\"mailto:PR@nanostherapeutics.com\" target=\"_blank\" rel=\"nofollow noopener\">PR@nanostherapeutics.com<\/a>\n\n<\/div>\n<\/div>\n<\/section><\/article>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\r\n\t\t\t\t<\/div>\r\n\t\t\t\t\t\t\t\t<\/div>\r\n\t\t\t<\/section>\r\n\t\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>DALLAS-Oct. 31, 2024 &#8212; Nanoscope Therapeutics, Inc., a BLA filing-stage biotechnology company developing gene therapies for retinal degenerative diseases, today announced that positive 2-year results from the Phase\u00a02b\u00a0RESTORE randomized, controlled clinical trial (RCT) of its lead program, MCO-010,\u00a0a mutation-agnostic gene therapy for patients with permanent and severe vision loss from advanced retinitis pigmentosa (RP) were presented by\u00a0Allen C. Ho, MD, FACS, FASRS, Director of Retina Research and Co-Director of the Retina Service at Wills Eye Hospital, and Chief Medical Advisor of Nanoscope, on\u00a0October 20, 2024 at the recently concluded\u00a0AAO 2024 Annual Meeting. During his presentation titled &#8220;Efficacy and Safety of MCO-010 Optogenetic Therapy for Vision Restoration in Patients With Severe [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":5852,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"footnotes":"","_links_to":"","_links_to_target":""},"categories":[13,8],"tags":[],"class_list":["post-5850","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-home-page","category-nanoscope-press-release"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Nanoscope Presented Positive 2-Year Randomized, Controlled Trial Results of MCO-010 for Retinitis Pigmentosa - Nanoscope Therapeutics<\/title>\n<meta name=\"description\" content=\"Our multi-characteristic opsin (MCO) platform is the first to demonstrate an ability to restore vision to retinal disease patients with severe vision loss in clincial trials. Nanoscope has developed MCO-010, the first and only broad spectrum, fast response and ultra-sensitive optogenetic technology for vision restoration that is gene-agnostic.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/nanostherapeutics.com\/ja\/2024\/10\/31\/nanoscope-presented-positive-2-year-randomized-controlled-trial-results-of-mco-010-for-retinitis-pigmentosa\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nanoscope Presented Positive 2-Year Randomized, Controlled Trial Results of MCO-010 for Retinitis Pigmentosa - Nanoscope Therapeutics\" \/>\n<meta property=\"og:description\" content=\"Our multi-characteristic opsin (MCO) platform is the first to demonstrate an ability to restore vision to retinal disease patients with severe vision loss in clincial trials. 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