{"id":10293,"date":"2026-09-09T06:06:11","date_gmt":"2026-09-09T11:06:11","guid":{"rendered":"https:\/\/nanostherapeutics.com\/?p=10293"},"modified":"2026-09-09T06:25:48","modified_gmt":"2026-09-09T11:25:48","slug":"nanoscope-therapeutics-announces-u-s-food-and-drug-administration-acceptance-of-biologics-license-application-for-mogenry-for-the-treatment-of-retinitis-pigmentosa-with-severe-vision-loss","status":"publish","type":"post","link":"https:\/\/nanostherapeutics.com\/ja\/2026\/09\/09\/nanoscope-therapeutics-announces-u-s-food-and-drug-administration-acceptance-of-biologics-license-application-for-mogenry-for-the-treatment-of-retinitis-pigmentosa-with-severe-vision-loss\/","title":{"rendered":"\u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u30fb\u30bb\u30e9\u30d4\u30e5\u30fc\u30c6\u30a3\u30af\u30b9\u793e\u3001\u91cd\u5ea6\u306e\u8996\u529b\u4f4e\u4e0b\u3092\u4f34\u3046\u7db2\u819c\u8272\u7d20\u5909\u6027\u75c7\u306e\u6cbb\u7642\u85acMOGENRY\u306e\u751f\u7269\u88fd\u5264\u627f\u8a8d\u7533\u8acb\u304c\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u306b\u53d7\u7406\u3055\u308c\u305f\u3053\u3068\u3092\u767a\u8868"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"10293\" class=\"elementor elementor-10293\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-6d5ad04f elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"6d5ad04f\" 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-5bf9bdef\" data-id=\"5bf9bdef\" 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-e3a8c93 elementor-widget elementor-widget-text-editor\" data-id=\"e3a8c93\" 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\t<ul><li><i>\u627f\u8a8d\u3055\u308c\u308c\u3070\u3001MOGENRY\u306f\u91cd\u5ea6\u306e\u8996\u529b\u4f4e\u4e0b\u3092\u4f34\u3046\u7db2\u819c\u8272\u7d20\u5909\u6027\u75c7\u60a3\u8005\u306b\u3068\u3063\u3066\u3001\u907a\u4f1d\u5b50\u691c\u67fb\u3092\u5fc5\u8981\u3068\u3057\u306a\u3044\u521d\u306e\u6cbb\u7642\u6cd5\u3068\u306a\u308b\u3002<\/i><\/li><li><i>BLA\u306f\u3001RESTORE\u7b2c2b\/3\u76f8\u8a66\u9a13\u306e\u826f\u597d\u306a\u30c7\u30fc\u30bf\u304a\u3088\u3073REMAIN\u9577\u671f\u8ffd\u8de1\u8abf\u67fb\u30c7\u30fc\u30bf\u306b\u3088\u3063\u3066\u88cf\u4ed8\u3051\u3089\u308c\u3066\u3044\u308b\u3002<\/i><\/li><\/ul><p><span class=\"legendSpanClass\">\u30c0\u30e9\u30b9<\/span>,\u00a0<span class=\"legendSpanClass\">2026\u5e749\u67089\u65e5<\/span>\u00a0\u2014\u00a0<a href=\"http:\/\/nanostherapeutics.com\/ja\/\" target=\"_blank\" rel=\"nofollow noopener\">\u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u30fb\u30bb\u30e9\u30d4\u30e5\u30fc\u30c6\u30a3\u30af\u30b9<\/a>, \u7db2\u819c\u5909\u6027\u306b\u3088\u308b\u5149\u53d7\u5bb9\u4f53\u55aa\u5931\u304a\u3088\u3073\u8996\u899a\u969c\u5bb3\u3092\u6709\u3059\u308b\u60a3\u8005\u5411\u3051\u306b\u3001\u75be\u60a3\u3092\u554f\u308f\u306a\u3044\u65b0\u898f\u6cbb\u7642\u6cd5\u306e\u958b\u767a\u304a\u3088\u3073\u5546\u696d\u5316\u306b\u6ce8\u529b\u3059\u308b\u30d0\u30a4\u30aa\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u4f01\u696d\u3067\u3042\u308bNanoscope, Inc.\uff08\u4ee5\u4e0b\u300cNanoscope\u300d\uff09\u306f\u672c\u65e5\u3001\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u304c\u3001Nanoscope\u306e\u627f\u8a8d\u3092\u6c42\u3081\u308b\u751f\u7269\u88fd\u5264\u627f\u8a8d\u7533\u8acb\uff08BLA\uff09\u3092\u53d7\u7406\u3057\u3001\u63d0\u51fa\u3057\u305f\u3053\u3068\u3092\u767a\u8868\u3057\u307e\u3057\u305f\u3002\u00a0<b>\u30e2\u30fc\u30b2\u30f3\u30ea\u30fc<\/b><b><sup>\u00ae<\/sup><\/b><b>\u00a0\uff08\u30bd\u30f3\u30d4\u30ec\u30c1\u30b2\u30f3\u30fb\u30a4\u30b9\u30c6\u30d1\u30eb\u30dc\u30d9\u30c3\u30af\u3001MCO-010\uff09<\/b>, \u3053\u308c\u306f\u3001\u91cd\u5ea6\u306e\u8996\u529b\u4f4e\u4e0b\u3092\u4f34\u3046\u7db2\u819c\u8272\u7d20\u5909\u6027\u75c7\uff08RP\uff09\u60a3\u8005\u306e\u8996\u529b\u56de\u5fa9\u3092\u76ee\u7684\u3068\u3057\u305f\u5149\u907a\u4f1d\u5b66\u7684\u907a\u4f1d\u5b50\u6cbb\u7642\u3067\u3042\u308b\u3002.<\/p><p>\u201c\u300cFDA\u304cMOGENRY\u306e\u751f\u7269\u88fd\u5264\u627f\u8a8d\u7533\u8acb\uff08BLA\uff09\u3092\u53d7\u7406\u3057\u63d0\u51fa\u3057\u305f\u3053\u3068\u306f\u3001\u6975\u3081\u3066\u91cd\u8981\u306a\u7bc0\u76ee\u3067\u3042\u308a\u3001\u73fe\u5728\u627f\u8a8d\u3055\u308c\u305f\u6cbb\u7642\u6cd5\u304c\u306a\u3044\u91cd\u5ea6\u306e\u8996\u529b\u4f4e\u4e0b\u3092\u4f34\u3046\u7db2\u819c\u8272\u7d20\u5909\u6027\u75c7\u60a3\u8005\u306e\u65b9\u3005\u306b\u30011\u56de\u9650\u308a\u306e\u9662\u5185\u6cbb\u7642\u30aa\u30d7\u30b7\u30e7\u30f3\u3092\u63d0\u4f9b\u3059\u308b\u3068\u3044\u3046\u76ee\u6a19\u306b\u5927\u304d\u304f\u8fd1\u3065\u304f\u3082\u306e\u3067\u3059\u300d\u3068\u3001Nanoscope Therapeutics\u306e\u6700\u9ad8\u7d4c\u55b6\u8cac\u4efb\u8005\uff08CEO\uff09\u3067\u3042\u308bSulagna Bhattacharya\u6c0f\u306f\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002\u300cRESTORE\u8a66\u9a13\u306e\u30c7\u30fc\u30bf\u306e\u5f37\u3055\u3068\u3001REMAIN\u8a66\u9a13\u306b\u304a\u3051\u308b\u9577\u671f\u8ffd\u8de1\u8abf\u67fb\u3067\u78ba\u8a8d\u3055\u308c\u305f\u6301\u7d9a\u6027\u304b\u3089\u3001MOGENRY\u304c\u91cd\u5ea6\u306e\u8996\u529b\u4f4e\u4e0b\u3092\u4f34\u3046\u7db2\u819c\u8272\u7d20\u5909\u6027\u75c7\u60a3\u8005\u306e\u65b0\u305f\u306a\u6a19\u6e96\u6cbb\u7642\u3068\u306a\u308b\u53ef\u80fd\u6027\u306b\u78ba\u4fe1\u3092\u6301\u3063\u3066\u3044\u307e\u3059\u3002FDA\u306e\u5be9\u67fb\u671f\u9593\u4e2d\u3001\u7dca\u5bc6\u306b\u9023\u643a\u3057\u3066\u3044\u304f\u3053\u3068\u3092\u697d\u3057\u307f\u306b\u3057\u3066\u3044\u307e\u3059\u3002\u300d\u201d<\/p><p>BLA\u306f\u3001\u7b2c1\/2a\u76f8\u8a66\u9a13\uff08<a href=\"https:\/\/clinicaltrials.gov\/study\/NCT04919473\" target=\"_blank\" rel=\"nofollow noopener\">NCT04919473<\/a>\uff09\u3001\u304a\u3088\u3073 RESTORE \u7b2c 2b\/3 \u76f8\u591a\u65bd\u8a2d\u5171\u540c\u3001\u7121\u4f5c\u70ba\u5316\u3001\u4e8c\u91cd\u76f2\u691c\u3001\u30d7\u30e9\u30bb\u30dc\u5bfe\u7167\u81e8\u5e8a\u8a66\u9a13 (<a href=\"https:\/\/clinicaltrials.gov\/study\/NCT04945772\" target=\"_blank\" rel=\"nofollow noopener\">NCT04945772<\/a>RESTORE\u8a66\u9a13\u306f\u4e3b\u8981\u8a55\u4fa1\u9805\u76ee\u304a\u3088\u3073\u4e3b\u8981\u526f\u6b21\u8a55\u4fa1\u9805\u76ee\u3092\u9054\u6210\u3057\u300152\u9031\u76ee\u304a\u3088\u307376\u9031\u76ee\u306b\u8996\u529b\u6539\u5584\u304c\u8a8d\u3081\u3089\u308c\u307e\u3057\u305f\u3002MOGENRY\u306f\u5fcd\u5bb9\u6027\u304c\u826f\u597d\u3067\u3001\u6cbb\u7642\u306b\u95a2\u9023\u3057\u305f\u91cd\u7be4\u306a\u6709\u5bb3\u4e8b\u8c61\u306f\u5831\u544a\u3055\u308c\u307e\u305b\u3093\u3067\u3057\u305f\u3002.<\/p><p>\u201c\u300c\u8996\u529b\u56de\u5fa9\u306f\u773c\u79d1\u907a\u4f1d\u5b50\u6cbb\u7642\u306b\u304a\u3044\u3066\u9054\u6210\u3059\u308b\u306e\u304c\u6700\u3082\u96e3\u3057\u3044\u76ee\u6a19\u3067\u3059\u304c\u3001MOGENRY\u306f\u9577\u5e74\u306b\u308f\u305f\u308b\u8996\u529b\u6539\u5584\u3068\u76f8\u307e\u3063\u3066\u3001\u305d\u306e\u30cf\u30fc\u30c9\u30eb\u3092\u30af\u30ea\u30a2\u3057\u3064\u3064\u3042\u308b\u3088\u3046\u3067\u3059\u3002\u3053\u306e\u7d44\u307f\u5408\u308f\u305b\u306f\u3001\u6e80\u305f\u3055\u308c\u3066\u3044\u306a\u3044\u30cb\u30fc\u30ba\u3092\u62b1\u3048\u308b\u60a3\u8005\u69d8\u3084Nanoscope\u793e\u3060\u3051\u3067\u306a\u304f\u3001\u773c\u79d1\u5206\u91ce\u5168\u4f53\u306b\u3068\u3063\u3066\u753b\u671f\u7684\u306a\u51fa\u6765\u4e8b\u3067\u3059\u3002MOGENRY\u306f\u907a\u4f1d\u5b50\u691c\u67fb\u3084\u624b\u8853\u5ba4\u3067\u306e\u6295\u4e0e\u3092\u5fc5\u8981\u3068\u3057\u306a\u3044\u305f\u3081\u3001\u5730\u57df\u306e\u7db2\u819c\u5c02\u9580\u533b\u306b\u3088\u308b\u5e45\u5e83\u3044\u5c0e\u5165\u304c\u671f\u5f85\u3067\u304d\u307e\u3059\u3002\u627f\u8a8d\u3055\u308c\u308c\u3070\u3001MOGENRY\u306f\u4e09\u6b21\u533b\u7642\u6a5f\u95a2\u3092\u5229\u7528\u3067\u304d\u306a\u3044\u60a3\u8005\u69d8\u306b\u3082\u624b\u306e\u5c4a\u304f\u7db2\u819c\u8272\u7d20\u5909\u6027\u75c7\u6cbb\u7642\u306e\u65b0\u6642\u4ee3\u3092\u5207\u308a\u958b\u304f\u3053\u3068\u306b\u306a\u308b\u3067\u3057\u3087\u3046\u300d\u3068\u3001\u30c8\u30fc\u30de\u30b9\u30fb\u30b8\u30a7\u30d5\u30a1\u30fc\u30bd\u30f3\u5927\u5b66\u773c\u79d1\u5b66\u6559\u6388\u3001\u30a6\u30a3\u30eb\u30ba\u773c\u79d1\u75c5\u9662\u7db2\u819c\u7814\u7a76\u90e8\u9577\u3001Nanoscope Therapeutics\u793e\u6700\u9ad8\u533b\u7642\u9867\u554f\u306eAllen C. Ho\u533b\u5e2b\u306f\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002.\u00a0<\/p><p>RESTORE\u8a66\u9a13\u3067\u6295\u4e0e\u3092\u53d7\u3051\u305f\u60a3\u8005\u306e\u307b\u3068\u3093\u3069\u306f\u3001REMAIN\u8a66\u9a13\u306b\u3082\u53c2\u52a0\u3057\u3066\u304a\u308a\u3001\u3053\u306e\u8a66\u9a13\u306f\u751f\u7269\u88fd\u5264\u627f\u8a8d\u7533\u8acb\uff08BLA\uff09\u306b\u304a\u3044\u3066\u9577\u671f\u8ffd\u8de1\u30c7\u30fc\u30bf\u3092\u63d0\u4f9b\u3057\u3066\u3044\u308b\u3002\u627f\u8a8d\u3055\u308c\u308c\u3070\u3001MOGENRY\u306f\u91cd\u5ea6\u306e\u8996\u529b\u4f4e\u4e0b\u3092\u4f34\u3046\u7db2\u819c\u8272\u7d20\u5909\u6027\u75c7\uff08RP\uff09\u60a3\u8005\u306e\u8996\u529b\u6539\u5584\u3092\u76ee\u7684\u3068\u3057\u305f\u3001\u521d\u306e\u907a\u4f1d\u5b50\u975e\u4f9d\u5b58\u578b\u6cbb\u7642\u85ac\u3068\u306a\u308b\u3002.<\/p><p>\u201c\u300c\u7db2\u819c\u5c02\u9580\u533b\u3068\u3057\u3066\u3001\u79c1\u305f\u3061\u306f\u591a\u304f\u306e\u6709\u671b\u306a\u85ac\u5264\u5019\u88dc\u304c\u3001\u60a3\u8005\u306b\u52b9\u679c\u3092\u793a\u3059\u3069\u3053\u308d\u304b\u3001\u305d\u306e\u52b9\u679c\u3092\u6301\u7d9a\u3055\u305b\u308b\u3053\u3068\u3055\u3048\u3067\u304d\u306a\u3044\u306e\u3092\u76ee\u306e\u5f53\u305f\u308a\u306b\u3057\u3066\u304d\u307e\u3057\u305f\u3002MOGENRY\u306e\u7279\u5fb4\u306f\u3001\u6570\u5e74\u306b\u308f\u305f\u3063\u3066\u52b9\u679c\u304c\u6301\u7d9a\u3059\u308b\u3068\u3044\u3046\u8a3c\u62e0\u306b\u57fa\u3065\u3044\u305f\u3001\u610f\u7fa9\u306e\u3042\u308b\u52b9\u679c\u3067\u3059\u3002\u9577\u671f\u306b\u308f\u305f\u308b\u52b9\u679c\u306e\u6301\u7d9a\u6027\u306f\u3001\u533b\u5e2b\u304c1\u56de\u306e\u6cbb\u7642\u3067\u307e\u3055\u306b\u5fc5\u8981\u3068\u3059\u308b\u3082\u306e\u3067\u3042\u308a\u3001\u60a3\u8005\u304c\u672c\u5f53\u306b\u983c\u308a\u306b\u3067\u304d\u308b\u3068\u78ba\u4fe1\u3067\u304d\u308b\u3082\u306e\u3067\u3059\u300d\u3068\u3001\u30ab\u30ea\u30d5\u30a9\u30eb\u30cb\u30a2\u5927\u5b66\u30ed\u30b5\u30f3\u30bc\u30eb\u30b9\u6821\u30c7\u30d3\u30c3\u30c9\u30fb\u30b2\u30d5\u30a3\u30f3\u533b\u5b66\u90e8\u304a\u3088\u3073\u30c9\u30d8\u30cb\u30fc\u773c\u79d1\u7814\u7a76\u6240\u306e\u81e8\u5e8a\u773c\u79d1\u5b66\u306e\u5bc4\u4ed8\u8b1b\u5ea7\u6559\u6388\u3067\u3042\u308a\u3001Nanoscope\u306e\u30d3\u30b8\u30e7\u30ca\u30ea\u30fc\u8aee\u554f\u59d4\u54e1\u4f1a\u306e\u59d4\u54e1\u9577\u3067\u3082\u3042\u308bSriniVas Sadda\u533b\u5e2b\u306f\u8ff0\u3079\u3066\u3044\u307e\u3059\u3002.<\/p><p><b>\u7db2\u819c\u8272\u7d20\u5909\u6027\u75c7\u306b\u3064\u3044\u3066<br class=\"dnr\" \/><\/b>\u7db2\u819c\u8272\u7d20\u5909\u6027\u75c7\uff08RP\uff09\u306f\u3001\u5149\u53d7\u5bb9\u4f53\u7d30\u80de\u304c\u5f90\u3005\u306b\u5909\u6027\u3057\u3001\u8996\u529b\u4f4e\u4e0b\u3068\u6700\u7d42\u7684\u306a\u5931\u660e\u306b\u81f3\u308b\u7a00\u306a\u907a\u4f1d\u6027\u75be\u60a3\u7fa4\u3067\u3059\u3002RP\u306f100\u4ee5\u4e0a\u306e\u907a\u4f1d\u5b50\u306b\u304a\u3051\u308b1,000\u4ee5\u4e0a\u306e\u5909\u7570\u3068\u95a2\u9023\u3057\u3066\u3044\u307e\u3059\u3002\u7c73\u56fd\u3067\u306f\u3001\u52b4\u50cd\u5e74\u9f62\u4eba\u53e3\u306b\u304a\u3051\u308b\u5931\u660e\u306e\u4e3b\u8981\u539f\u56e0\u306e\u4e00\u3064\u3067\u3042\u308a\u300110\u4e07\u4eba\u4ee5\u4e0a\u304c\u7f79\u60a3\u3057\u3001\u305d\u306e\u3046\u30612\u4e075\u5343\u4eba\u4ee5\u4e0a\u304c\u6cd5\u7684\u5931\u660e\u72b6\u614b\u306b\u3042\u308a\u307e\u3059\u3002\u8996\u529b\u4f4e\u4e0b\u306e\u901f\u5ea6\u306f\u6839\u672c\u7684\u306a\u5909\u7570\u306b\u3088\u3063\u3066\u7570\u306a\u308a\u307e\u3059\u304c\u3001\u60a3\u8005\u306f\u5e73\u5747\u3057\u3066\u5e74\u9593\u7d040.03 LogMAR\uff08\u7d041.5\u6587\u5b57\uff09\u306e\u8996\u529b\u4f4e\u4e0b\u3092\u7d4c\u9a13\u3057\u3001\u3053\u308c\u306f3\u5e74\u3054\u3068\u306b\u8996\u529b\u691c\u67fb\u8868\u306e1\u884c\u5206\u306b\u76f8\u5f53\u3057\u307e\u3059\u3002\u5927\u591a\u6570\u306e\u60a3\u8005\u306f60\u6b73\u307e\u3067\u306b\u6cd5\u7684\u5931\u660e\u72b6\u614b\uff0820\/200\u672a\u6e80\uff09\u306b\u306a\u308a\u307e\u3059\u3002.<\/p><p><b>MOGENRY\uff08sonpiretigene isteparvovec\u3001MCO-010\uff09\u306b\u3064\u3044\u3066<br class=\"dnr\" \/><\/b>\u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u793e\u306e\u591a\u7279\u6027\u30aa\u30d7\u30b7\u30f3\uff08MCO\uff09\u6280\u8853\u306f\u3001\u72ec\u81ea\u306e\u907a\u4f1d\u5b50\u64cd\u4f5c\u5408\u6210\u30aa\u30d7\u30b7\u30f3\u3092\u5229\u7528\u3057\u3066\u3001\u5e83\u7bc4\u56f2\u306e\u5149\u30b9\u30da\u30af\u30c8\u30eb\u306b\u308f\u305f\u308b\u9ad8\u3044\u5149\u611f\u5ea6\u3068\u9ad8\u901f\u306a\u53cd\u5fdc\u901f\u5ea6\u3068\u3044\u3046\u70b9\u3067\u6700\u9069\u306a\u6027\u80fd\u3092\u5b9f\u73fe\u3057\u307e\u3059\u3002\u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u793e\u306e\u5171\u540c\u5275\u696d\u8005\u3001\u793e\u9577\u517c\u6700\u9ad8\u79d1\u5b66\u8cac\u4efb\u8005\u3067\u3042\u308b\u30b5\u30de\u30ec\u30f3\u30c9\u30e9\u30fb\u30e2\u30cf\u30f3\u30c6\u30a3\u6c0f\u304c\u3053\u306e\u6280\u8853\u3092\u69cb\u60f3\u30fb\u767a\u660e\u3057\u305f\u5f8c\u3001\u5f7c\u306e\u30c1\u30fc\u30e0\u306f10\u5e74\u4ee5\u4e0a\u306b\u308f\u305f\u308a\u3001\u8907\u6570\u306e\u52d5\u7269\u30e2\u30c7\u30eb\u3068\u30d2\u30c8\u75be\u60a3\u306b\u304a\u3051\u308b\u305d\u306e\u6027\u80fd\u3092\u8a55\u4fa1\u3057\u3066\u304d\u307e\u3057\u305f\u3002MOGENRY\u306f\u3001\u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u793e\u306eMCO\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3092\u57fa\u76e4\u3068\u3057\u305f\u3001\u6cbb\u9a13\u6bb5\u968e\u306e1\u56de\u9650\u308a\u306e\u9662\u5185\u785d\u5b50\u4f53\u5185\u5149\u907a\u4f1d\u5b66\u7684\u907a\u4f1d\u5b50\u6cbb\u7642\u3067\u3059\u3002MOGENRY\u306f\u3001\u9ad8\u5bc6\u5ea6\u306e\u53cc\u6975\u7db2\u819c\u7d30\u80de\u306b\u591a\u7279\u6027\u30aa\u30d7\u30b7\u30f3\u907a\u4f1d\u5b50\u3092\u6295\u4e0e\u3059\u308b\u3053\u3068\u3067\u3001\u3053\u308c\u3089\u306e\u751f\u5b58\u7d30\u80de\u3092\u76f4\u63a5\u5149\u611f\u53d7\u6027\u306b\u3057\u3001\u5149\u53d7\u5bb9\u4f53\u306e\u55aa\u5931\u5f8c\u3082\u6b8b\u5b58\u3059\u308b\u8996\u899a\u56de\u8def\u3092\u5229\u7528\u3067\u304d\u308b\u3088\u3046\u306b\u3057\u307e\u3059\u3002MOGENRY\u306f\u3001\u907a\u4f1d\u5b50\u691c\u67fb\u3001\u4fb5\u8972\u7684\u306a\u624b\u8853\u3001\u307e\u305f\u306f\u7e70\u308a\u8fd4\u3057\u6295\u4e0e\u3092\u5fc5\u8981\u3068\u305b\u305a\u3001\u65e2\u5b58\u306e\u7db2\u819c\u8a3a\u7642\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u5185\u3067\u6295\u4e0e\u3067\u304d\u308b\u3088\u3046\u306b\u8a2d\u8a08\u3055\u308c\u3066\u3044\u307e\u3059\u3002.<\/p><p><b>\u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u30fb\u30bb\u30e9\u30d4\u30e5\u30fc\u30c6\u30a3\u30af\u30b9\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\u7db2\u819c\u5909\u6027\u75be\u60a3\u306b\u3088\u308a\u5931\u660e\u3057\u305f\u6570\u767e\u4e07\u4eba\u306e\u60a3\u8005\u306e\u305f\u3081\u306b\u3001\u75be\u60a3\u306e\u7a2e\u985e\u3092\u554f\u308f\u305a\u8996\u529b\u3092\u56de\u5fa9\u3055\u305b\u308b\u5149\u907a\u4f1d\u5b66\u7684\u6cbb\u7642\u6cd5\u3092\u958b\u767a\u3057\u3066\u3044\u307e\u3059\u3002\u7db2\u819c\u8272\u7d20\u5909\u6027\u75c7\uff08RP\uff09\u3092\u5bfe\u8c61\u3068\u3057\u305f\u591a\u65bd\u8a2d\u5171\u540c\u7121\u4f5c\u70ba\u5316\u4e8c\u91cd\u76f2\u691c\u30d7\u30e9\u30bb\u30dc\u5bfe\u7167\u81e8\u5e8a\u8a66\u9a13\u3067\u3042\u308bRESTORE\u7b2c2b\/3\u76f8\u8a66\u9a13\u3067\u826f\u597d\u306a\u7d50\u679c\u304c\u5f97\u3089\u308c\u305f\u3053\u3068\u3092\u53d7\u3051\u3001<a href=\"https:\/\/clinicaltrials.gov\/study\/NCT04945772\" target=\"_blank\" rel=\"nofollow noopener\">NCT04945772<\/a>\uff09\u3001FDA\u306fMOGENRY\u306eBLA\u3092\u53d7\u7406\u3057\u3001\u63d0\u51fa\u3057\u307e\u3057\u305f\u3002\u627f\u8a8d\u3055\u308c\u308c\u3070\u3001MOGENRY\u306f\u907a\u4f1d\u5b50\u691c\u67fb\u3092\u5fc5\u8981\u3068\u305b\u305a\u3001\u8a3a\u7642\u6240\u30671\u56de\u6ce8\u5c04\u3059\u308b\u3060\u3051\u3067\u6295\u4e0e\u3067\u304d\u308b\u305f\u3081\u3001RP\u60a3\u8005\u306e\u6a19\u6e96\u6cbb\u7642\u3068\u306a\u308b\u53ef\u80fd\u6027\u304c\u3042\u308a\u307e\u3059\u3002\u5f53\u793e\u306f\u307e\u305f\u3001\u30b9\u30bf\u30fc\u30ac\u30eb\u30c8\u75c5\uff08SD\uff09\uff08<a href=\"https:\/\/clinicaltrials.gov\/study\/NCT05417126\" target=\"_blank\" rel=\"nofollow noopener\">NCT05417126<\/a>\uff09\u3067\u3042\u308a\u30012026\u5e74\u306b\u7b2c3\u76f8\u767b\u9332\u8a66\u9a13\u3092\u958b\u59cb\u3059\u308b\u4e88\u5b9a\u3067\u3059\u3002MCO-010\u306f\u3001RP\u3068SD\u306e\u4e21\u65b9\u3067FDA\u306e\u30d5\u30a1\u30b9\u30c8\u30c8\u30e9\u30c3\u30af\u304a\u3088\u3073\u30aa\u30fc\u30d5\u30a1\u30f3\u30c9\u30e9\u30c3\u30b0\u6307\u5b9a\u3092\u53d7\u3051\u3066\u304a\u308a\u3001SD\u306b\u3064\u3044\u3066\u306fRMAT\u6307\u5b9a\u3082\u53d7\u3051\u3066\u3044\u307e\u3059\u3002\u307e\u305f\u3001\u975e\u75c7\u5019\u6027\u304a\u3088\u3073\u75c7\u5019\u6027\u306e\u687f\u4f53\u304a\u3088\u3073\u9310\u4f53\u512a\u4f4d\u6027\u30b8\u30b9\u30c8\u30ed\u30d5\u30a3\u30fc\u3001\u306a\u3089\u3073\u306b\u9ec4\u6591\u30b8\u30b9\u30c8\u30ed\u30d5\u30a3\u30fc\u3092\u5bfe\u8c61\u3068\u3057\u305fEMA\u306e\u30aa\u30fc\u30d5\u30a1\u30f3\u6307\u5b9a\u3082\u53d7\u3051\u3066\u3044\u307e\u3059\u3002MCO-010\u306f\u3001\u65e5\u672c\u3067\u306f\u907a\u4f1d\u6027\u7db2\u819c\u30b8\u30b9\u30c8\u30ed\u30d5\u30a3\u30fc\uff08IRD\uff09\u306e\u5148\u99c6\u3051\u6307\u5b9a\u304a\u3088\u3073\u30aa\u30fc\u30d5\u30a1\u30f3\u6307\u5b9a\u3092\u53d7\u3051\u3066\u304a\u308a\u3001\u30b5\u30a6\u30b8\u30a2\u30e9\u30d3\u30a2\u3067\u306fIRD\u306e\u30aa\u30fc\u30d5\u30a1\u30f3\u6307\u5b9a\u3092\u53d7\u3051\u3066\u3044\u307e\u3059\u3002\u5730\u7406\u7684\u840e\u7e2e\u75c7\u306b\u5bfe\u3059\u308bMCO\u306e\u7b2c2\u76f8\u30d7\u30ed\u30b0\u30e9\u30e0\u306f2026\u5e74\u306b\u958b\u59cb\u3055\u308c\u308b\u4e88\u5b9a\u3067\u3042\u308a\u3001IND\u6e96\u5099\u4e2d\u306e\u4ed6\u306e\u30d7\u30ed\u30b0\u30e9\u30e0\u306b\u306f\u30ec\u30fc\u30d0\u30fc\u5148\u5929\u6027\u9ed2\u5185\u969c\uff08LCA\uff09\u304c\u542b\u307e\u308c\u307e\u3059\u3002.<\/p><p><b>\u30e1\u30c7\u30a3\u30a2<br class=\"dnr\" \/><\/b>\u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u30fb\u30bb\u30e9\u30d4\u30e5\u30fc\u30c6\u30a3\u30af\u30b9\u793e<br class=\"dnr\" \/>(817) 857-1186<br class=\"dnr\" \/><a href=\"mailto:PR@nanostherapeutics.com\" target=\"_blank\" rel=\"nofollow noopener\">PR@nanostherapeutics.com<\/a><\/p>\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>If approved, MOGENRY would be the first gene-agnostic treatment available for patients with retinitis pigmentosa having severe vision loss BLA supported by positive RESTORE Phase 2b\/3 data and REMAIN long-term follow-up data DALLAS,\u00a0Sept. 9, 2026\u00a0&#8212;\u00a0Nanoscope Therapeutics, Inc. (&#8220;Nanoscope&#8221;), a biotechnology company focused on developing and commercializing novel, disease\u2011agnostic therapies for patients with photoreceptor loss and vision impairment due to retinal degeneration,\u00a0today announced that the U.S. Food and Drug Administration (FDA) has accepted and filed the Biologics License Application (BLA) seeking approval of\u00a0MOGENRY\u00ae\u00a0(sonpiretigene isteparvovec, MCO-010), an optogenetic gene therapy designed for vision restoration for patients with retinitis pigmentosa (RP) having severe vision loss. &#8220;FDA acceptance and filing of our BLA for [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":10294,"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-10293","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 v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Nanoscope Therapeutics Announces U.S. Food and Drug Administration Acceptance of Biologics License Application for MOGENRY for the Treatment of Retinitis Pigmentosa with Severe Vision Loss - 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\/2026\/09\/09\/nanoscope-therapeutics-announces-u-s-food-and-drug-administration-acceptance-of-biologics-license-application-for-mogenry-for-the-treatment-of-retinitis-pigmentosa-with-severe-vision-loss\/\" \/>\n<meta property=\"og:locale\" content=\"ja_JP\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nanoscope Therapeutics Announces U.S. Food and Drug Administration Acceptance of Biologics License Application for MOGENRY for the Treatment of Retinitis Pigmentosa with Severe Vision Loss - 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. 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 property=\"og:url\" content=\"https:\/\/nanostherapeutics.com\/ja\/2026\/09\/09\/nanoscope-therapeutics-announces-u-s-food-and-drug-administration-acceptance-of-biologics-license-application-for-mogenry-for-the-treatment-of-retinitis-pigmentosa-with-severe-vision-loss\/\" \/>\n<meta property=\"og:site_name\" content=\"Nanoscope Therapeutics\" \/>\n<meta property=\"article:published_time\" content=\"2026-09-09T11:06:11+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-09-09T11:25:48+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/nanostherapeutics.com\/wp-content\/uploads\/2025\/06\/NSCOPE_nu_Logo_Horizontal_2Color_1200px.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"242\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Wilson PJ\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@NSTherapeutics\" \/>\n<meta name=\"twitter:site\" content=\"@NSTherapeutics\" \/>\n<meta name=\"twitter:label1\" content=\"\u57f7\u7b46\u8005\" \/>\n\t<meta name=\"twitter:data1\" content=\"Wilson PJ\" \/>\n\t<meta name=\"twitter:label2\" content=\"\u63a8\u5b9a\u8aad\u307f\u53d6\u308a\u6642\u9593\" \/>\n\t<meta name=\"twitter:data2\" content=\"5\u5206\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/2026\\\/09\\\/09\\\/nanoscope-therapeutics-announces-u-s-food-and-drug-administration-acceptance-of-biologics-license-application-for-mogenry-for-the-treatment-of-retinitis-pigmentosa-with-severe-vision-loss\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/2026\\\/09\\\/09\\\/nanoscope-therapeutics-announces-u-s-food-and-drug-administration-acceptance-of-biologics-license-application-for-mogenry-for-the-treatment-of-retinitis-pigmentosa-with-severe-vision-loss\\\/\"},\"author\":{\"name\":\"Wilson PJ\",\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/#\\\/schema\\\/person\\\/2fa4c7d9fcf90c2c01f1341935baf02d\"},\"headline\":\"Nanoscope Therapeutics Announces U.S. Food and Drug Administration Acceptance of Biologics License Application for MOGENRY for the Treatment of Retinitis Pigmentosa with Severe Vision Loss\",\"datePublished\":\"2026-09-09T11:06:11+00:00\",\"dateModified\":\"2026-09-09T11:25:48+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/2026\\\/09\\\/09\\\/nanoscope-therapeutics-announces-u-s-food-and-drug-administration-acceptance-of-biologics-license-application-for-mogenry-for-the-treatment-of-retinitis-pigmentosa-with-severe-vision-loss\\\/\"},\"wordCount\":1001,\"publisher\":{\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/2026\\\/09\\\/09\\\/nanoscope-therapeutics-announces-u-s-food-and-drug-administration-acceptance-of-biologics-license-application-for-mogenry-for-the-treatment-of-retinitis-pigmentosa-with-severe-vision-loss\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/nanostherapeutics.com\\\/wp-content\\\/uploads\\\/NSCOPE_25-LI_BLA_Accept_V3C.jpg\",\"articleSection\":[\"Home Page\",\"Nanoscope Press Release\"],\"inLanguage\":\"ja\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/2026\\\/09\\\/09\\\/nanoscope-therapeutics-announces-u-s-food-and-drug-administration-acceptance-of-biologics-license-application-for-mogenry-for-the-treatment-of-retinitis-pigmentosa-with-severe-vision-loss\\\/\",\"url\":\"https:\\\/\\\/nanostherapeutics.com\\\/2026\\\/09\\\/09\\\/nanoscope-therapeutics-announces-u-s-food-and-drug-administration-acceptance-of-biologics-license-application-for-mogenry-for-the-treatment-of-retinitis-pigmentosa-with-severe-vision-loss\\\/\",\"name\":\"Nanoscope Therapeutics Announces U.S. Food and Drug Administration Acceptance of Biologics License Application for MOGENRY for the Treatment of Retinitis Pigmentosa with Severe Vision Loss - 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