{"id":10045,"date":"2026-01-20T06:19:51","date_gmt":"2026-01-20T12:19:51","guid":{"rendered":"https:\/\/nanostherapeutics.com\/?p=10045"},"modified":"2026-02-24T06:42:00","modified_gmt":"2026-02-24T12:42:00","slug":"nanoscope-secures-japan-mhlw-sakigake-and-orphan-drug-designations-across-inherited-retinal-diseases-a-first-for-a-retinal-gene-therapy","status":"publish","type":"post","link":"https:\/\/nanostherapeutics.com\/es\/2026\/01\/20\/nanoscope-secures-japan-mhlw-sakigake-and-orphan-drug-designations-across-inherited-retinal-diseases-a-first-for-a-retinal-gene-therapy\/","title":{"rendered":"Nanoscope obtiene las designaciones de medicamento hu\u00e9rfano y Sakigake del Ministerio de Salud, Trabajo y Bienestar de Jap\u00f3n para diversas enfermedades retinianas hereditarias: un hito para la terapia g\u00e9nica de la retina."},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"10045\" class=\"elementor elementor-10045\" 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<h3 style=\"text-align: center;\"><em><strong>Japan&#8217;s Ministry of Health, Labor and Welfare (MHLW) grants MCO-010 Pioneering Regenerative Medical Product (Sakigake) and Orphan Drug designations,<\/strong>\u00a0permitir una v\u00eda regulatoria acelerada para tratar a pacientes con p\u00e9rdida grave de visi\u00f3n debido a enfermedades retinianas hereditarias<\/em><\/h3><h3 style=\"text-align: center;\"><em><strong>Se basa en un fuerte impulso regulatorio global,<\/strong> incluyendo cinco designaciones de medicamentos hu\u00e9rfanos por la EMA y m\u00faltiples programas acelerados de la FDA para indicaciones retinianas.<\/em><\/h3><h3 style=\"text-align: center;\"><em><strong>La FDA, la EMA y la PMDA aprueban condicionalmente la marca MOGENRY\u2122.\u00a0<\/strong>for MCO-010 as Nanoscope&#8217;s rolling BLA\u00a0with the FDA\u00a0for retinitis pigmentosa advances<\/em><\/h3><h3 style=\"text-align: center;\"><em><strong>El MCO-010 se posiciona para estar listo para su precomercializaci\u00f3n global en los principales mercados.,<\/strong> reinforcing Nanoscope&#8217;s leadership in optogenetic therapy<\/em><\/h3><p><span class=\"legendSpanClass\">DALLAS<\/span>,\u00a0<span class=\"legendSpanClass\">20 de enero de 2026<\/span>\u00a0 \u2014 <a href=\"http:\/\/nanostherapeutics.com\/es\/\" target=\"_blank\" rel=\"nofollow noopener\">Nanoscope Therapeutics, Inc.<\/a>, a biotechnology company committed to developing and commercializing novel, disease-agnostic therapies for patients with photoreceptor loss and vision impairment due to retinal degeneration,\u00a0today announced that Japan&#8217;s Ministry of Health, Labour and Welfare\u00a0(MHLW) has granted\u00a0<b>Sakigake y Hu\u00e9rfano\u00a0<\/b><b>Droga\u00a0<\/b><b>designaciones para MCO-010<\/b>, Nanoscope&#8217;s lead asset to treat patients with severe vision loss from inherited retinal diseases (IRDs).<\/p><p>The\u00a0Sakigake designation, Japan&#8217;s premier fast-track regulatory program for innovative therapies addressing serious unmet medical needs, is designed to accelerate patient access to breakthrough treatments. Sakigake status enables prioritized regulatory consultation and review\u2014often targeting a\u00a0six-month review timeline\u2014through close collaboration with the Pharmaceuticals and Medical Devices Agency (PMDA) and may support\u00a0premium pricing\u00a0following approval. Combined with Orphan Drug designation (for use in less than 50,000 patients with high medical need), the decision establishes a strong\u00a0regulatory pathway for MCO-010 in Japan.<b>\u00a0MCO-010 es\u00a0<\/b><b>La primera terapia g\u00e9nica para la retina en recibir las designaciones de Sakigake y de medicamento hu\u00e9rfano.<\/b><\/p><p>&#8220;These designations from Japan&#8217;s MHLW mark another\u00a0pivotal milestone for Nanoscope,&#8221; said\u00a0<a href=\"https:\/\/nanostherapeutics.com\/es\/who-we-are\/samarendra-mohanty\/\" target=\"_blank\" rel=\"nofollow noopener\">Samarendra Mohanty, PhD, Presidente y Director Cient\u00edfico de Nanoscope Therapeutics.<\/a>. &#8220;Sakigake recognition underscores the novelty of MCO-010 as a one-time, in-office intravitreal optogenetic therapy and its potential to address profound vision loss where no approved treatments exist. Together with our progress in the U.S. and Europe, we are advancing one of the most comprehensive global regulatory strategies in optogenetic retinal gene therapy for patients living with inherited retinal diseases.&#8221;<\/p><p><b>Fuerte impulso regulatorio en los principales mercados.<\/b><\/p><p>The MHLW&#8217;s decision builds on accelerated regulatory pathways across other major markets:<\/p><ul type=\"disc\"><li><b>Uni\u00f3n Europea (EMA):<\/b>\u00a0Cinco designaciones de enfermedades raras que abarcan distrofias no sindr\u00f3micas y sindr\u00f3micas con predominio de bastones y conos, as\u00ed como distrofias maculares.<\/li><li><b>Estados Unidos (FDA):<\/b><br \/><ul type=\"circle\"><li>Designaciones de medicamento hu\u00e9rfano y v\u00eda r\u00e1pida para la retinosis pigmentaria (RP)<\/li><li>Designaciones de Medicamento Hu\u00e9rfano, V\u00eda R\u00e1pida y Terapia Avanzada de Medicina Regenerativa (RMAT) para la enfermedad de Stargardt (SD)<\/li><\/ul><\/li><\/ul><p>Adem\u00e1s, el\u00a0<b>La FDA, la EMA y la PMDA tienen\u00a0<\/b><b>condicionalmente\u00a0<\/b><b>Se aprob\u00f3 la marca MOGENRY\u2122 para MCO-010.<\/b>, mientras Nanoscope contin\u00faa avanzando en su\u00a0<b>Solicitud de licencia para productos biol\u00f3gicos (BLA) en curso\u00a0<\/b><b>para aprobaci\u00f3n de marketing\u00a0<\/b><b>para RP<\/b><b>\u00a0pacientes<\/b>\u00a0en los Estados Unidos.<\/p><p>Con estas v\u00edas regulatorias ya establecidas en\u00a0<b>Jap\u00f3n, Estados Unidos y Europa, MCO-010 representa el<\/b>\u00a0<b>La plataforma de terapia optogen\u00e9tica m\u00e1s avanzada en desarrollo a nivel mundial.<\/b>. Estas designaciones coordinadas respaldan la aceleraci\u00f3n de los plazos de desarrollo, una mayor colaboraci\u00f3n con los organismos reguladores y la oportunidad de ser la primera terapia optogen\u00e9tica aprobada en los principales mercados.<\/p><p><b>Acerca de la plataforma MCO<br class=\"dnr\" \/><\/b>MCO es una plataforma terap\u00e9utica intrav\u00edtrea de una sola aplicaci\u00f3n, ambulatoria y aplicable a cualquier enfermedad, dise\u00f1ada para restaurar la visi\u00f3n en pacientes con degeneraci\u00f3n de fotorreceptores, incluyendo retinosis pigmentaria (RP), enfermedad de Stargardt (ES) y atrofia geogr\u00e1fica (AG). Al activar las c\u00e9lulas bipolares de la retina, altamente densas, para que sean sensibles a la luz, MCO aprovecha el circuito visual restante tras la muerte de los fotorreceptores. El tratamiento con MCO no requiere pruebas gen\u00e9ticas, cirug\u00eda invasiva ni dosis repetidas, lo que permite una amplia aplicabilidad en pacientes dentro de los flujos de trabajo habituales en las consultas de retina.<\/p><p><b>Acerca de Nanoscope Therapeutics<br class=\"dnr\" \/><\/b>Nanoscope Therapeutics est\u00e1 desarrollando una terapia optogen\u00e9tica restauradora de la visi\u00f3n, independiente de la enfermedad, para millones de pacientes ciegos por enfermedades degenerativas de la retina. Tras los resultados positivos del ensayo cl\u00ednico multic\u00e9ntrico, aleatorizado, doble ciego y controlado con placebo RESTORE Fase 2b\/3 para la retinosis pigmentaria (RP) (<a href=\"https:\/\/clinicaltrials.gov\/study\/NCT04945772\" target=\"_blank\" rel=\"nofollow noopener\">NCT04945772<\/a>), se ha iniciado una presentaci\u00f3n continua de BLA a la FDA. Si se aprueba, MCO-010 tiene el potencial de ser el tratamiento est\u00e1ndar para pacientes con RP, administrado como una inyecci\u00f3n \u00fanica en el consultorio sin necesidad de pruebas gen\u00e9ticas. La compa\u00f1\u00eda tambi\u00e9n ha mostrado resultados prometedores en el ensayo cl\u00ednico de fase 2 STARLIGHT de MCO-010 en la enfermedad de Stargardt (SD) (<a href=\"https:\/\/clinicaltrials.gov\/study\/NCT05417126\" target=\"_blank\" rel=\"nofollow noopener\">NCT05417126<\/a>) y planea iniciar una\u00a0<a href=\"https:\/\/nanostherapeutics.com\/es\/2024\/09\/12\/nanoscope-therapeutics-announces-end-of-phase-2-meeting-with-u-s-fda-and-plan-to-initiate-a-phase-3-clinical-trial-of-mco-010-to-treat-stargardt-macular-degeneration\/\" target=\"_blank\" rel=\"nofollow noopener\">Ensayo de registro de fase 3<\/a>\u00a0A principios de 2026, MCO-010 recibi\u00f3 las designaciones de v\u00eda r\u00e1pida y medicamento hu\u00e9rfano de la FDA para RP y SD, junto con la designaci\u00f3n RMAT para SD, y las designaciones de medicamento hu\u00e9rfano de la EMA para cubrir distrofias dominantes de bastones y conos no sindr\u00f3micas y sindr\u00f3micas, as\u00ed como distrofias maculares. Se espera que un programa de fase 2 para MCO en atrofia geogr\u00e1fica (GA) comience a principios de 2026. Otros programas listos para IND incluyen la amaurosis cong\u00e9nita de Leber (LCA).<\/p><p><b>Contacto:<br class=\"dnr\" \/><\/b>Nanoscope Therapeutics, Inc<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><p>FUENTE Terap\u00e9utica del Nanoscopio<\/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>Japan&#8217;s Ministry of Health, Labor and Welfare (MHLW) grants MCO-010 Pioneering Regenerative Medical Product (Sakigake) and Orphan Drug designations,\u00a0enabling an accelerated regulatory pathway to treat patients with severe vision loss from inherited retinal diseases Builds on strong global regulatory momentum, including five EMA Orphan designations and multiple FDA expedited programs across retinal indications FDA, EMA [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":10046,"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-10045","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 v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Nanoscope Secures Japan MHLW Sakigake and Orphan Drug Designations Across Inherited Retinal Diseases - A First for a Retinal Gene Therapy - 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\/es\/2026\/01\/20\/nanoscope-secures-japan-mhlw-sakigake-and-orphan-drug-designations-across-inherited-retinal-diseases-a-first-for-a-retinal-gene-therapy\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nanoscope Secures Japan MHLW Sakigake and Orphan Drug Designations Across Inherited Retinal Diseases - A First for a Retinal Gene Therapy - 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\/es\/2026\/01\/20\/nanoscope-secures-japan-mhlw-sakigake-and-orphan-drug-designations-across-inherited-retinal-diseases-a-first-for-a-retinal-gene-therapy\/\" \/>\n<meta property=\"og:site_name\" content=\"Nanoscope Therapeutics\" \/>\n<meta property=\"article:published_time\" content=\"2026-01-20T12:19:51+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-24T12:42:00+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=\"Nanoscope Therapeutics\" \/>\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=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Nanoscope Therapeutics\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/2026\\\/01\\\/20\\\/nanoscope-secures-japan-mhlw-sakigake-and-orphan-drug-designations-across-inherited-retinal-diseases-a-first-for-a-retinal-gene-therapy\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/2026\\\/01\\\/20\\\/nanoscope-secures-japan-mhlw-sakigake-and-orphan-drug-designations-across-inherited-retinal-diseases-a-first-for-a-retinal-gene-therapy\\\/\"},\"author\":{\"name\":\"Nanoscope Therapeutics\",\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/#\\\/schema\\\/person\\\/5aeedc9aef0946fe8f96f98f7b1808a2\"},\"headline\":\"Nanoscope Secures Japan MHLW Sakigake and Orphan Drug Designations Across Inherited Retinal Diseases &#8211; A First for a Retinal Gene Therapy\",\"datePublished\":\"2026-01-20T12:19:51+00:00\",\"dateModified\":\"2026-02-24T12:42:00+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/2026\\\/01\\\/20\\\/nanoscope-secures-japan-mhlw-sakigake-and-orphan-drug-designations-across-inherited-retinal-diseases-a-first-for-a-retinal-gene-therapy\\\/\"},\"wordCount\":768,\"publisher\":{\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/2026\\\/01\\\/20\\\/nanoscope-secures-japan-mhlw-sakigake-and-orphan-drug-designations-across-inherited-retinal-diseases-a-first-for-a-retinal-gene-therapy\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/nanostherapeutics.com\\\/wp-content\\\/uploads\\\/NSCOPE_25-LI_JapanOrphanV3_REV1.jpg\",\"articleSection\":[\"Home Page\",\"Nanoscope Press Release\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/2026\\\/01\\\/20\\\/nanoscope-secures-japan-mhlw-sakigake-and-orphan-drug-designations-across-inherited-retinal-diseases-a-first-for-a-retinal-gene-therapy\\\/\",\"url\":\"https:\\\/\\\/nanostherapeutics.com\\\/2026\\\/01\\\/20\\\/nanoscope-secures-japan-mhlw-sakigake-and-orphan-drug-designations-across-inherited-retinal-diseases-a-first-for-a-retinal-gene-therapy\\\/\",\"name\":\"Nanoscope Secures Japan MHLW Sakigake and Orphan Drug Designations Across Inherited Retinal Diseases - A First for a Retinal Gene Therapy - Nanoscope Therapeutics\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/2026\\\/01\\\/20\\\/nanoscope-secures-japan-mhlw-sakigake-and-orphan-drug-designations-across-inherited-retinal-diseases-a-first-for-a-retinal-gene-therapy\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/2026\\\/01\\\/20\\\/nanoscope-secures-japan-mhlw-sakigake-and-orphan-drug-designations-across-inherited-retinal-diseases-a-first-for-a-retinal-gene-therapy\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/nanostherapeutics.com\\\/wp-content\\\/uploads\\\/NSCOPE_25-LI_JapanOrphanV3_REV1.jpg\",\"datePublished\":\"2026-01-20T12:19:51+00:00\",\"dateModified\":\"2026-02-24T12:42:00+00:00\",\"description\":\"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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