{"id":9454,"date":"2025-09-02T06:25:37","date_gmt":"2025-09-02T11:25:37","guid":{"rendered":"https:\/\/nanostherapeutics.com\/?p=9454"},"modified":"2025-10-13T06:34:02","modified_gmt":"2025-10-13T11:34:02","slug":"nanoscope-strengthens-global-regulatory-pathways-for-mco-010-with-fda-rmat-and-five-ema-orphan-designations","status":"publish","type":"post","link":"https:\/\/nanostherapeutics.com\/ja\/2025\/09\/02\/nanoscope-strengthens-global-regulatory-pathways-for-mco-010-with-fda-rmat-and-five-ema-orphan-designations\/","title":{"rendered":"\u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u793e\u3001FDA RMAT\u304a\u3088\u3073EMA\u306e\u5e0c\u5c11\u75be\u75c5\u7528\u533b\u85ac\u54c1\u6307\u5b9a5\u4ef6\u306b\u3088\u308a\u3001MCO-010\u306e\u30b0\u30ed\u30fc\u30d0\u30eb\u306a\u898f\u5236\u7d4c\u8def\u3092\u5f37\u5316"},"content":{"rendered":"
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<\/div><\/div><\/div><\/header>

\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\u306f\u3001MCO-010\u306b\u5bfe\u3057\u3001\u75c7\u5019\u6027\u304a\u3088\u3073\u975e\u75c7\u5019\u6027\u3001\u687f\u4f53\u512a\u4f4d\u578b\u304a\u3088\u3073\u9310\u4f53\u512a\u4f4d\u578b\u3001\u9ec4\u6591\u30b8\u30b9\u30c8\u30ed\u30d5\u30a3\u30fc\u306a\u3069\u3001\u5149\u53d7\u5bb9\u4f53\u55aa\u5931\u3092\u4f34\u3046\u5e45\u5e83\u3044\u7db2\u819c\u75be\u60a3\u306b\u5bfe\u3057\u3066\u30015\u3064\u306e\u5e0c\u5c11\u75be\u75c5\u7528\u533b\u85ac\u54c1\u6307\u5b9a\u3092\u4ed8\u4e0e\u3057\u305f\u3002.<\/i><\/h3>

\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u306f\u3001\u30b9\u30bf\u30fc\u30ac\u30eb\u30c8\u75c5\u6cbb\u7642\u85acMCO-010\u306b\u5bfe\u3057\u3001\u65e2\u5b58\u306e\u5e0c\u5c11\u75be\u75c5\u7528\u533b\u85ac\u54c1\u304a\u3088\u3073\u30d5\u30a1\u30b9\u30c8\u30c8\u30e9\u30c3\u30af\u6307\u5b9a\u306b\u52a0\u3048\u3001\u518d\u751f\u533b\u7642\u5148\u9032\u6cbb\u7642\uff08RMAT\uff09\u6307\u5b9a\u3092\u4ed8\u4e0e\u3057\u305f\u3002.<\/i><\/h3>

\u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u793e\u306f\u3001\u75be\u60a3\u306e\u7a2e\u985e\u3092\u554f\u308f\u306a\u3044MCO-010\u5149\u907a\u4f1d\u5b66\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u306b\u3088\u308a\u3001\u6cbb\u7642\u30cb\u30fc\u30ba\u306e\u9ad8\u3044\u7db2\u819c\u5909\u6027\u75be\u60a3\u306b\u5bfe\u3059\u308b\u6a19\u6e96\u6cbb\u7642\u3092\u518d\u5b9a\u7fa9\u3057\u3088\u3046\u3068\u3057\u3066\u3044\u307e\u3059\u3002.<\/i><\/h3><\/div><\/div><\/section>

\u30c0\u30e9\u30b9<\/span><\/span>,\u00a02025\u5e749\u67082\u65e5<\/span><\/span>\u00a0—\u00a0\u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u30fb\u30bb\u30e9\u30d4\u30e5\u30fc\u30c6\u30a3\u30af\u30b9\u682a\u5f0f\u4f1a\u793e<\/a>, \u7db2\u819c\u5909\u6027\u306b\u3088\u308b\u5149\u53d7\u5bb9\u4f53\u55aa\u5931\u304a\u3088\u3073\u8996\u529b\u969c\u5bb3\u306e\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\u53d6\u308a\u7d44\u3080\u30d0\u30a4\u30aa\u30c6\u30af\u30ce\u30ed\u30b8\u30fc\u4f01\u696d\u3067\u3042\u308b[\u4f1a\u793e\u540d]\u306f\u672c\u65e5\u3001\u6b27\u5dde\u533b\u85ac\u54c1\u5e81\uff08EMA\uff09\u304cMCO-010\uff08\u30bd\u30f3\u30d4\u30ec\u30c1\u30b2\u30f3\u30fb\u30a4\u30b9\u30c6\u30d1\u30eb\u30dc\u30d9\u30c3\u30af\uff09\u306b\u5bfe\u3057\u30015\u3064\u306e\u7db2\u819c\u30b8\u30b9\u30c8\u30ed\u30d5\u30a3\u30fc\u306e\u30ab\u30c6\u30b4\u30ea\u30fc\u306b\u308f\u305f\u308b\u5e0c\u5c11\u75be\u75c5\u7528\u533b\u85ac\u54c1\u6307\u5b9a\u3092\u4ed8\u4e0e\u3057\u305f\u3053\u3068\u3092\u767a\u8868\u3057\u307e\u3057\u305f\u3002\u3055\u3089\u306b\u3001\u7c73\u56fd\u98df\u54c1\u533b\u85ac\u54c1\u5c40\uff08FDA\uff09\u306f\u3001MCO-010\u306b\u5bfe\u3057\u3001\u30b9\u30bf\u30fc\u30ac\u30eb\u30c8\u75c5\uff08SD\uff09\u306b\u5bfe\u3059\u308bRMAT\u6307\u5b9a\u3092\u4ed8\u4e0e\u3057\u307e\u3057\u305f\u3002.<\/p>

The EMA Orphan designations cover non-syndromic and syndromic rod-dominant and cone-dominant dystrophies, as well as macular dystrophies, providing a potential disease-agnostic regulatory path forward for dozens of retinal conditions. The new FDA RMAT designation for SD builds on prior Orphan Drug and Fast Track designations for both retinitis pigmentosa (RP) and SD. The EMA and FDA actions underscore regulatory agency recognition of MCO-010’s potential to address significant unmet needs in retinal degenerative diseases.<\/p>

“Securing RMAT designation for Stargardt disease in addition to our prior FDA designations for SD and RP is a major validation for our therapies that warrant expedited development and review,” said\u00a0\u30b9\u30e9\u30cb\u30e3\u30fb\u30d0\u30bf\u30c1\u30e3\u30ea\u30e4<\/span>, CEO of Nanoscope. “Combined with five EMA Orphan designations, these achievements highlight the global momentum behind our MCO platform as a potential vision-restoring therapy for patients with few or no treatment options.”<\/p>

MCO\uff08\u591a\u7279\u6027\u30aa\u30d7\u30b7\u30f3\uff09\u306f\u3001\u7db2\u819c\u8272\u7d20\u5909\u6027\u75c7\uff08RP\uff09\u3001\u30bb\u30e9\u30d4\u30e5\u30fc\u30c6\u30a3\u30af\u30b9\uff08SD\uff09\u3001\u5730\u56f3\u72b6\u840e\u7e2e\uff08GA\uff09\u306a\u3069\u306e\u5149\u53d7\u5bb9\u4f53\u5909\u6027\u75c7\u60a3\u8005\u306e\u8996\u529b\u56de\u5fa9\u3092\u76ee\u7684\u3068\u3057\u305f\u3001\u75be\u60a3\u3092\u554f\u308f\u306a\u3044\u5358\u56de\u6295\u4e0e\u306e\u785d\u5b50\u4f53\u5185\u6cbb\u7642\u30d7\u30e9\u30c3\u30c8\u30d5\u30a9\u30fc\u30e0\u3067\u3059\u3002MCO\u306f\u3001\u9ad8\u5bc6\u5ea6\u306e\u53cc\u6975\u7db2\u819c\u7d30\u80de\u3092\u6d3b\u6027\u5316\u3057\u3066\u5149\u611f\u53d7\u6027\u306b\u3059\u308b\u3053\u3068\u3067\u3001\u5149\u53d7\u5bb9\u4f53\u6b7b\u5f8c\u306b\u6b8b\u5b58\u3059\u308b\u8996\u899a\u56de\u8def\u3092\u6d3b\u7528\u3057\u307e\u3059\u3002MCO\u306f\u907a\u4f1d\u5b50\u691c\u67fb\u3001\u5916\u79d1\u7684\u4ecb\u5165\u3001\u53cd\u5fa9\u6295\u4e0e\u3092\u5fc5\u8981\u3068\u3057\u306a\u3044\u305f\u3081\u3001\u65e2\u5b58\u306e\u7db2\u819c\u8a3a\u7642\u30ef\u30fc\u30af\u30d5\u30ed\u30fc\u5185\u3067\u5e45\u5e83\u3044\u60a3\u8005\u306b\u9069\u7528\u53ef\u80fd\u3067\u3059\u3002.<\/p>

Nanoscope’s vision-improving clinical programs are advancing globally, with positive Phase\u00a02b<\/span>\u7db2\u819c\u8272\u7d20\u5909\u6027\u75c7\uff08RP\uff09\u306b\u304a\u3051\u308bRESTORE\u8a66\u9a13\u306e\u7b2c3\u76f8\u8a66\u9a13\u7d50\u679c\u3068\u3001\u810a\u9ac4\u6027\u7b4b\u708e\uff08SD\uff09\u306b\u304a\u3051\u308bSTARLIGHT\u7b2c2\u76f8\u8a66\u9a13\u306e\u6709\u671b\u306a\u7d50\u679c\u304c\u5831\u544a\u3055\u308c\u3066\u3044\u307e\u3059\u3002SD\u306b\u304a\u3051\u308b\u7b2c3\u76f8\u627f\u8a8d\u7533\u8acb\u8a66\u9a13\u3068\u3001GA\u306b\u304a\u3051\u308b\u7b2c2\u76f8\u8a66\u9a13\u306f\u30012025\u5e74\u672b\u307e\u3067\u306b\u958b\u59cb\u3055\u308c\u308b\u4e88\u5b9a\u3067\u3059\u3002.<\/p>

\u7db2\u819c\u5909\u6027\u75be\u60a3\uff08\u7db2\u819c\u8272\u7d20\u5909\u6027\u75c7\u3001\u30bb\u30ed\u30c8\u30cb\u30f3\u518d\u53d6\u308a\u8fbc\u307f\u963b\u5bb3\u85ac\u3001\u9ec4\u6591\u30b8\u30b9\u30c8\u30ed\u30d5\u30a3\u30fc\u3001\u75c7\u5019\u6027\u7db2\u819c\u75be\u60a3\u306a\u3069\uff09\u306f\u3001\u4e16\u754c\u4e2d\u3067\u6570\u767e\u4e07\u4eba\u306e\u60a3\u8005\u306b\u5f71\u97ff\u3092\u4e0e\u3048\u3066\u3044\u307e\u3059\u3002\u3053\u308c\u3089\u306e\u75be\u60a3\u306f\u751f\u6d3b\u3092\u5927\u304d\u304f\u5909\u3048\u3001\u6162\u6027\u7684\u306b\u8870\u5f31\u3055\u305b\u3001\u5e83\u304f\u6709\u52b9\u306a\u6cbb\u7642\u6cd5\u304c\u4e0d\u8db3\u3057\u3066\u3044\u307e\u3059\u3002\u6b27\u5dde\u9023\u5408\u3067\u306f\u3001EMA\u306e\u5e0c\u5c11\u75be\u75c5\u7528\u533b\u85ac\u54c1\u6307\u5b9a\u306b\u3088\u308a\u3001\u30d7\u30ed\u30c8\u30b3\u30eb\u652f\u63f4\u3084\u627f\u8a8d\u5f8c\u6700\u592710\u5e74\u9593\u306e\u5e02\u5834\u72ec\u5360\u6a29\u304c\u4ed8\u4e0e\u3055\u308c\u307e\u3059\u3002\u00a0\u7c73\u56fd<\/span>, \u5e0c\u5c11\u75be\u75c5\u7528\u533b\u85ac\u54c1\u3001\u30d5\u30a1\u30b9\u30c8\u30c8\u30e9\u30c3\u30af\u3001RMAT\u306e\u6307\u5b9a\u3092\u53d7\u3051\u308b\u3053\u3068\u3067\u3001\u958b\u767a\u3068\u5be9\u67fb\u306e\u8fc5\u901f\u5316\u3001\u6cbb\u9a13\u8a2d\u8a08\u306e\u67d4\u8edf\u6027\u3001\u627f\u8a8d\u5f8c\u306e7\u5e74\u9593\u306e\u5e02\u5834\u72ec\u5360\u6a29\u3068\u3044\u3063\u305f\u6a5f\u4f1a\u304c\u5f97\u3089\u308c\u307e\u3059\u3002.<\/p>

\u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u30fb\u30bb\u30e9\u30d4\u30e5\u30fc\u30c6\u30a3\u30af\u30b9\u306b\u3064\u3044\u3066<\/b><\/p>

\u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u30fb\u30bb\u30e9\u30d4\u30e5\u30fc\u30c6\u30a3\u30af\u30b9\u793e\u306f\u3001\u7db2\u819c\u5909\u6027\u75be\u60a3\u3067\u5931\u660e\u3057\u305f\u6570\u767e\u4e07\u4eba\u306e\u60a3\u8005\u3092\u5bfe\u8c61\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\u3002RESTORE\u30d5\u30a7\u30fc\u30ba\u3067\u306e\u826f\u597d\u306a\u7d50\u679c\u3092\u53d7\u3051\u3066\u3001\u00a02b<\/span>\/3 \u7db2\u819c\u8272\u7d20\u5909\u6027\u75c7\uff08RP\uff09\u306b\u5bfe\u3059\u308b\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\uff08NCT04945772<\/a>\uff09\u3001FDA\u3078\u306eBLA\u7533\u8acb\u304c\u9806\u6b21\u958b\u59cb\u3055\u308c\u3066\u3044\u307e\u3059\u3002\u627f\u8a8d\u3055\u308c\u308c\u3070\u3001MCO-010\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\u540c\u793e\u306f\u307e\u305f\u3001\u30b9\u30bf\u30fc\u30ac\u30eb\u30c8\u75c5\uff08SD\uff09\uff08NCT05417126<\/a>\uff09\u3092\u958b\u59cb\u3057\u3001\u00a0\u30d5\u30a7\u30fc\u30ba3\u767b\u9332\u8a66\u9a13<\/a>\u00a02025\u5e74\u306b\u3001MCO-010\u306f\u3001\u7db2\u819c\u8272\u7d20\u5909\u6027\u75c7\uff08RP\uff09\u3068\u30b9\u30bf\u30d5\u30a3\u30f3\u30fb\u30c7\u30a3\u30d5\u30a3\u30b7\u30eb\uff08SD\uff09\u306e\u4e21\u65b9\u3067FDA\u306e\u30d5\u30a1\u30b9\u30c8\u30c8\u30e9\u30c3\u30af\u304a\u3088\u3073\u5e0c\u5c11\u75be\u75c5\u7528\u533b\u85ac\u54c1\u6307\u5b9a\u3092\u53d7\u3051\u3001SD\u3067\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\u30fb\u9310\u4f53\u512a\u4f4d\u6027\u30b8\u30b9\u30c8\u30ed\u30d5\u30a3\u30fc\u3001\u9ec4\u6591\u30b8\u30b9\u30c8\u30ed\u30d5\u30a3\u30fc\u3092\u5bfe\u8c61\u3068\u3059\u308bEMA\u306e\u5e0c\u5c11\u75be\u75c5\u7528\u533b\u85ac\u54c1\u6307\u5b9a\u3082\u53d7\u3051\u3066\u3044\u307e\u3059\u3002\u5730\u7406\u7684\u840e\u7e2e\uff08GA\uff09\u306b\u304a\u3051\u308bMCO\u306e\u7b2c2\u76f8\u30d7\u30ed\u30b0\u30e9\u30e0\u306f\u30012025\u5e74\u672b\u307e\u3067\u306b\u958b\u59cb\u3055\u308c\u308b\u4e88\u5b9a\u3067\u3059\u3002IND\u7533\u8acb\u6e96\u5099\u304c\u6574\u3063\u3066\u3044\u308b\u305d\u306e\u4ed6\u306e\u30d7\u30ed\u30b0\u30e9\u30e0\u306b\u306f\u3001\u30ec\u30fc\u30d0\u30fc\u5148\u5929\u6027\u9ed2\u5185\u969c\uff08LCA\uff09\u304c\u3042\u308a\u307e\u3059\u3002.<\/p>

\u63a5\u89e6\uff1a
<\/b>\u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u30fb\u30bb\u30e9\u30d4\u30e5\u30fc\u30c6\u30a3\u30af\u30b9
(817) 857-1186
PR@nanostherapeutics.com<\/a><\/p>

\u51fa\u5178 \u30ca\u30ce\u30b9\u30b3\u30fc\u30d7\u30fb\u30bb\u30e9\u30d4\u30e5\u30fc\u30c6\u30a3\u30af\u30b9<\/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":"

European Medicines Agency grants MCO-010 five Orphan designations across a wide spectrum of retinal diseases involving photoreceptor loss, including syndromic and non-syndromic, rod- and cone-dominant, and macular dystrophies. FDA grants MCO-010 Regenerative Medicine Advanced Therapy (RMAT) designation, in addition to current Orphan Drug and Fast Track designations, for Stargardt disease. Nanoscope is redefining the standard of care for high unmet need retinal degenerations with its disease-agnostic MCO-010 optogenetic platform. DALLAS,\u00a0Sept. 2, 2025\u00a0—\u00a0Nanoscope Therapeutics Inc., a biotechnology company committed to developing and commercializing novel disease-agnostic therapies for patients with photoreceptor loss and vision impairment from retinal degeneration, today announced that the European Medicines Agency (EMA) has granted Orphan designations to MCO-010 […]<\/p>\n","protected":false},"author":6,"featured_media":8971,"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-9454","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-home-page","category-nanoscope-press-release"],"yoast_head":"\nNanoscope Strengthens Global Regulatory Pathways for MCO-010 with FDA RMAT and Five EMA Orphan Designations - 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. 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