{"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>El Ministerio de Salud, Trabajo y Bienestar de Jap\u00f3n (MHLW) otorga al MCO-010 las designaciones de Producto M\u00e9dico Regenerativo Pionero (Sakigake) y Medicamento Hu\u00e9rfano,<\/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>para MCO-010 como la solicitud de licencia biol\u00f3gica continua de Nanoscope ante la FDA para los avances en retinosis pigmentaria<\/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> reforzando el liderazgo de Nanoscope en terapia optogen\u00e9tica.<\/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>, una empresa de biotecnolog\u00eda comprometida con el desarrollo y la comercializaci\u00f3n de terapias novedosas e independientes de la enfermedad para pacientes con p\u00e9rdida de fotorreceptores y discapacidad visual debido a la degeneraci\u00f3n retiniana, anunci\u00f3 hoy que el Ministerio de Salud, Trabajo y Bienestar de Jap\u00f3n (MHLW) le ha otorgado\u00a0<b>Sakigake y Hu\u00e9rfano\u00a0<\/b><b>Droga\u00a0<\/b><b>designaciones para MCO-010<\/b>, el principal producto de Nanoscope para tratar a pacientes con p\u00e9rdida grave de visi\u00f3n debido a enfermedades retinianas hereditarias (ERH).<\/p><p>La designaci\u00f3n Sakigake, el principal programa regulatorio acelerado de Jap\u00f3n para terapias innovadoras que abordan necesidades m\u00e9dicas graves no cubiertas, est\u00e1 dise\u00f1ada para acelerar el acceso de los pacientes a tratamientos revolucionarios. El estatus Sakigake permite una consulta y revisi\u00f3n regulatoria prioritaria \u2014a menudo con un plazo de revisi\u00f3n de seis meses\u2014 mediante una estrecha colaboraci\u00f3n con la Agencia de Productos Farmac\u00e9uticos y Dispositivos M\u00e9dicos (PMDA) y puede respaldar precios m\u00e1s altos tras la aprobaci\u00f3n. En combinaci\u00f3n con la designaci\u00f3n de medicamento hu\u00e9rfano (para su uso en menos de 50\u00a0000 pacientes con necesidades m\u00e9dicas graves), esta decisi\u00f3n establece una s\u00f3lida v\u00eda regulatoria para MCO-010 en Jap\u00f3n.<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>\u201cEstas designaciones del Ministerio de Salud, Trabajo y Bienestar de Jap\u00f3n marcan otro hito fundamental para Nanoscope\u201d, dijo\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>. El reconocimiento de Sakigake subraya la novedad de MCO-010 como terapia optogen\u00e9tica intrav\u00edtrea de una sola aplicaci\u00f3n en consulta y su potencial para abordar la p\u00e9rdida profunda de visi\u00f3n en casos donde no existen tratamientos aprobados. Junto con nuestros avances en EE. UU. y Europa, estamos impulsando una de las estrategias regulatorias globales m\u00e1s completas en terapia g\u00e9nica retiniana optogen\u00e9tica para pacientes con enfermedades retinianas hereditarias.\u201c<\/p><p><b>Fuerte impulso regulatorio en los principales mercados.<\/b><\/p><p>La decisi\u00f3n del MHLW se basa en los procesos regulatorios acelerados que se han implementado en otros mercados importantes:<\/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\u2019s 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,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"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 v27.6 - 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. 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