{"id":5634,"date":"2024-01-18T09:41:56","date_gmt":"2024-01-18T15:41:56","guid":{"rendered":"https:\/\/nanostherapeutics.com\/?p=5634"},"modified":"2025-06-27T11:24:42","modified_gmt":"2025-06-27T16:24:42","slug":"nanoscope-therapeutics-provides-regulatory-update-on-mco-010-for-the-treatment-of-retinitis-pigmentosa","status":"publish","type":"post","link":"https:\/\/nanostherapeutics.com\/es\/2024\/01\/18\/nanoscope-therapeutics-provides-regulatory-update-on-mco-010-for-the-treatment-of-retinitis-pigmentosa\/","title":{"rendered":"Nanoscope Therapeutics proporciona actualizaci\u00f3n regulatoria sobre MCO-010 para el tratamiento de la retinitis pigmentosa"},"content":{"rendered":"<div class=\"col-sm-8 col-vcenter col-xs-12\">\n<div class=\"col-sm-8 col-vcenter col-xs-12\">\n<h1><\/h1>\n<\/div>\n<\/div>\n<article class=\"news-release inline-gallery-template\">\n<section class=\"release-body container\">\n<div class=\"row\">\n<div class=\"col-lg-10 col-lg-offset-1\">\n<ul type=\"disc\">\n<li><strong><i>Los reguladores de la FDA y la UE brindan asesoramiento constante sobre que la agudeza visual puede servir como criterio de valoraci\u00f3n principal para evaluar la eficacia de MCO-010 en el tratamiento de pacientes con retinitis pigmentosa (RP) con baja visi\u00f3n.<\/i><\/strong><\/li>\n<li><strong><i>La informaci\u00f3n regulatoria proporciona claridad sobre el posible camino hacia la aprobaci\u00f3n en los EE. UU. y en\u00a0<span class=\"xn-location\">Europa<\/span>\u00a0para MCO-010 en RP; Nanoscopio prepar\u00e1ndose para ejecuci\u00f3n inmediata<\/i><\/strong><\/li>\n<\/ul>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">DALLAS<\/span><\/span>,\u00a0<span class=\"legendSpanClass\"><span class=\"xn-chron\">18 de enero de 2024<\/span><\/span> \u2014\u00a0<a href=\"https:\/\/c212.net\/c\/link\/?t=0&l=en&o=4071016-1&h=2117084114&u=https%3A%2F%2Fnanostherapeutics.com%2F&a=Nanoscope+Therapeutics+Inc.\" target=\"_blank\" rel=\"nofollow noopener\">Nanoscopio Therapeutics Inc.<\/a>, una empresa de biotecnolog\u00eda cl\u00ednica en fase avanzada que desarrolla terapias g\u00e9nicas para enfermedades retinianas hereditarias y degeneraciones maculares relacionadas con la edad (DMAE), proporcion\u00f3 hoy una actualizaci\u00f3n tras las recientes conversaciones regulatorias con la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (&quot;FDA&quot;) y de la reuni\u00f3n de asesoramiento cient\u00edfico con la Agencia Islandesa de Medicamentos (&quot;IMA&quot;), con respecto a la v\u00eda regulatoria de MCO-010 para el tratamiento de la retinosis pigmentaria.<\/p>\n<p>En relaci\u00f3n con la productiva discusi\u00f3n de fin de fase 2 tipo B con la FDA, Nanoscope recibi\u00f3 comentarios sobre su programa de terapia g\u00e9nica optogen\u00e9tica MCO-010 en pacientes con p\u00e9rdida grave de visi\u00f3n debido a RP avanzada. La FDA declar\u00f3 que el cambio desde el valor inicial en una medida de agudeza visual en pacientes con baja visi\u00f3n podr\u00eda ser una evaluaci\u00f3n primaria apropiada de la eficacia en un estudio adecuado y bien controlado para proporcionar evidencia sustancial de beneficio para respaldar la aprobaci\u00f3n de BLA. MCO-010 ha recibido designaciones de medicamento hu\u00e9rfano y de v\u00eda r\u00e1pida de la FDA.<\/p>\n<p>Nanoscope tambi\u00e9n recibi\u00f3 comentarios positivos de una reuni\u00f3n de asesoramiento cient\u00edfico con la IMA como parte del proceso de aprobaci\u00f3n para MCO-010 en\u00a0<span class=\"xn-location\">Europa<\/span>.<\/p>\n<p class=\"prnml40\" style=\"padding-left: 40px;\">La IMA respald\u00f3 la agudeza visual como el criterio de valoraci\u00f3n principal apropiado para evaluar a los pacientes con RP con baja visi\u00f3n despu\u00e9s del tratamiento con MCO-010.<\/p>\n<p class=\"prnml40\" style=\"padding-left: 40px;\">La IMA tambi\u00e9n respald\u00f3 un cambio de 0,3 logMAR como cl\u00ednicamente significativo para los pacientes con RP con p\u00e9rdida grave de visi\u00f3n.<\/p>\n<p class=\"prnml40\" style=\"padding-left: 40px;\">La IMA sugiri\u00f3 que Nanoscope explore la aprobaci\u00f3n condicional para MCO-010 en\u00a0<span class=\"xn-location\">Europa<\/span>\u00a0bas\u00e1ndose en los datos existentes.<\/p>\n<p>Basado en discusiones regulatorias, Nanoscope ha vuelto a considerar la agudeza visual como el criterio de valoraci\u00f3n principal en la fase multic\u00e9ntrica, aleatorizada y con doble enmascaramiento en curso.\u00a0<span class=\"xn-money\">2b<\/span>\u00a0estudio (RESTAURAR). Se espera que los datos de 100 semanas al final del estudio se informen en el primer semestre de 2024.<\/p>\n<p>\u201cLa informaci\u00f3n constante tanto de la FDA como de la IMA sobre el potencial de la agudeza visual para servir como criterio de valoraci\u00f3n principal del programa cl\u00ednico es un hito importante para Nanoscope y proporciona a MCO-010 una ruta regulatoria clara en los EE. UU. y en\u00a0<span class=\"xn-location\">Europa<\/span>,&quot; dicho\u00a0<span class=\"xn-person\">Sulagna Bhattacharya<\/span>, cofundador y director ejecutivo de Nanoscope.<\/p>\n<p><b>Acerca de la retinosis pigmentaria<br class=\"dnr\" \/><\/b>La retinosis pigmentaria (RP) engloba un grupo de trastornos gen\u00e9ticos raros en los que las c\u00e9lulas fotorreceptoras de la retina se degeneran con el tiempo, lo que provoca deterioro visual y, finalmente, ceguera. Se cree que estos trastornos est\u00e1n relacionados con m\u00e1s de 100 mutaciones gen\u00e9ticas diferentes. Aproximadamente 100\u00a0000 personas en Estados Unidos y unos 2 millones en todo el mundo padecen RP, lo que la convierte en la principal causa de ceguera hereditaria.<\/p>\n<p><b>Acerca de MCO-010<br class=\"dnr\" \/><\/b>Las terapias gen\u00e9ticas actuales tienen como objetivo tratar a pacientes con mutaciones gen\u00e9ticas espec\u00edficas y est\u00e1n a\u00fan m\u00e1s limitadas en enfermedades avanzadas con c\u00e9lulas degeneradas de la retina externa. La monoterapia optogen\u00e9tica MCO activable con luz ambiental se dirige a abundantes neuronas internas de la retina y tiene el potencial de restaurar la visi\u00f3n perdida permanentemente debido a la RP avanzada. MCO-010 (sonpiretigene isteparvovec, suspensi\u00f3n para inyecci\u00f3n intrav\u00edtrea) es la \u00fanica opsina de banda ancha, r\u00e1pida y m\u00e1s sensible a la luz que se encuentra actualmente en ensayos cl\u00ednicos. Con orientaci\u00f3n a c\u00e9lulas bipolares mediante el potenciador-promotor mGluR6, el casete de expresi\u00f3n MCO-010 est\u00e1 dise\u00f1ado para restaurar una visi\u00f3n de alta calidad en entornos del mundo real. El vector patentado AAV2 permite una transducci\u00f3n robusta de MCO-010 en c\u00e9lulas bipolares tras inyecci\u00f3n intrav\u00edtrea. El estudio de fase 1\/2 de MCO-010 en pacientes con RP avanzada demostr\u00f3 una seguridad favorable y una mejora de la agudeza visual dependiente de la dosis. Se observaron mejoras nominalmente significativas en la agudeza visual en los pacientes tratados con MCO-010 en comparaci\u00f3n con el control en la Fase\u00a0<span class=\"xn-money\">2b<\/span>\u00a0RESTAURAR prueba. Tambi\u00e9n hubo mejoras funcionales de la visi\u00f3n nominalmente significativas seg\u00fan lo evaluado por la movilidad guiada por visi\u00f3n de m\u00faltiples luminancias y la discriminaci\u00f3n de formas, junto con un perfil de seguridad favorable.<\/p>\n<p><b>Acerca de Nanoscope Therapeutics Inc.<br class=\"dnr\" \/><\/b>Nanoscope Therapeutics est\u00e1 desarrollando terapias optogen\u00e9ticas independientes del gen que restauran la visi\u00f3n para millones de pacientes ciegos por enfermedades retinianas hereditarias para las que no existe cura. El principal f\u00e1rmaco de la compa\u00f1\u00eda, MCO-010, inform\u00f3 recientemente los resultados preliminares de la fase RESTORE.\u00a0<span class=\"xn-money\">2b<\/span>\u00a0ensayo cl\u00ednico multic\u00e9ntrico, aleatorizado, doble enmascarado y controlado de forma simulada en los EE. UU. para la retinitis pigmentosa (<a href=\"https:\/\/c212.net\/c\/link\/?t=0&l=en&o=4071016-1&h=1764809894&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4009878-1%26h%3D4290035820%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3984630-1%2526h%253D517760235%2526u%253Dhttps%25253A%25252F%25252Fclinicaltrials.gov%25252Fct2%25252Fshow%25252FNCT04945772%25253Fterm%25253DNanoscope%252526draw%25253D2%2526a%253DNCT04945772%26a%3DNCT04945772&a=NCT04945772\" target=\"_blank\" rel=\"nofollow noopener\">NCT04945772<\/a>). La compa\u00f1\u00eda tambi\u00e9n complet\u00f3 recientemente el ensayo de fase 2 STARLIGHT de la terapia MCO-010 en pacientes con enfermedad de Stargardt (<a href=\"https:\/\/c212.net\/c\/link\/?t=0&l=en&o=4071016-1&h=831375813&u=https%3A%2F%2Fc212.net%2Fc%2Flink%2F%3Ft%3D0%26l%3Den%26o%3D4009878-1%26h%3D736901417%26u%3Dhttps%253A%252F%252Fc212.net%252Fc%252Flink%252F%253Ft%253D0%2526l%253Den%2526o%253D3984630-1%2526h%253D1090222651%2526u%253Dhttps%25253A%25252F%25252Fclinicaltrials.gov%25252Fct2%25252Fshow%25252FNCT05417126%25253Fterm%25253Dnanoscope%252526draw%25253D2%252526rank%25253D3%2526a%253DNCT05417126%26a%3DNCT05417126&a=NCT05417126\" target=\"_blank\" rel=\"nofollow noopener\">NCT05417126<\/a>\u00a0). MCO-010 ha recibido designaciones de v\u00eda r\u00e1pida de la FDA y designaciones de medicamento hu\u00e9rfano de la FDA tanto para la retinitis pigmentosa como para la enfermedad de Stargardt. Los activos precl\u00ednicos incluyen la terapia g\u00e9nica MCO-020 administrada con l\u00e1ser no viral para la atrofia geogr\u00e1fica.<\/p>\n<p><b>Contacto de inversores:<\/b><br class=\"dnr\" \/>Socios Argot<br class=\"dnr\" \/>212-600-1902<br class=\"dnr\" \/><a href=\"mailto:PR@nanostherapeutics.com\" target=\"_blank\" rel=\"nofollow noopener\">PR@nanostherapeutics.com<\/a><\/p>\n<p>FUENTE Terap\u00e9utica del Nanoscopio<\/p>\n<\/div>\n<\/div>\n<\/section>\n<\/article>","protected":false},"excerpt":{"rendered":"<p>FDA and EU Regulators provide consistent advice that visual acuity may serve as primary endpoint to evaluate the effectiveness of MCO-010 in the treatment of low-vision retinitis pigmentosa (RP) patients Regulatory feedback provides clarity for potential path to approval in the US and in\u00a0Europe\u00a0for MCO-010 in RP; Nanoscope preparing for immediate execution DALLAS,\u00a0Jan. 18, 2024 [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":5635,"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-5634","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 Therapeutics Provides Regulatory Update on MCO-010 for the Treatment of 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\/es\/2024\/01\/18\/nanoscope-therapeutics-provides-regulatory-update-on-mco-010-for-the-treatment-of-retinitis-pigmentosa\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nanoscope Therapeutics Provides Regulatory Update on MCO-010 for the Treatment of 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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