{"id":5822,"date":"2024-10-10T06:39:10","date_gmt":"2024-10-10T11:39:10","guid":{"rendered":"https:\/\/nanostherapeutics.com\/?p=5822"},"modified":"2025-06-27T08:35:21","modified_gmt":"2025-06-27T13:35:21","slug":"nanoscope-announces-plans-to-submit-bla-for-mco-010-to-treat-retinitis-pigmentosa","status":"publish","type":"post","link":"https:\/\/nanostherapeutics.com\/es\/2024\/10\/10\/nanoscope-announces-plans-to-submit-bla-for-mco-010-to-treat-retinitis-pigmentosa\/","title":{"rendered":"Nanoscope anuncia planes para presentar solicitud de autorizaci\u00f3n de comercializaci\u00f3n para el MCO-010 para tratar 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<div class=\"col-sm-8 col-vcenter col-xs-12\">\n<header class=\"container release-header\">\n<div class=\"custom-container\">\n<div class=\"row\">\n<div class=\"col-sm-12 col-xs-12\"><i style=\"color: #323334; font-size: revert; font-weight: 600; letter-spacing: -0.4095px;\">Reuni\u00f3n productiva de la FDA<\/i><i style=\"color: #323334; font-size: revert; font-weight: 600; letter-spacing: -0.4095px;\">\u00a0allana el camino para la presentaci\u00f3n de BLA para MCO-010 en el primer trimestre de 2025<\/i><\/div>\n<\/div>\n<\/div>\n<\/header>\n<\/div>\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<p><span class=\"legendSpanClass\"><span class=\"xn-location\">DALLAS<\/span><\/span>, TX \u2014 <span class=\"legendSpanClass\"><span class=\"xn-chron\">10 de octubre de 2024<\/span><\/span>\u00a0 \u2014 <a href=\"https:\/\/nanostherapeutics.com\/es\/\" target=\"_blank\" rel=\"nofollow noopener\">Nanoscopio Therapeutics Inc.<\/a>, una empresa de biotecnolog\u00eda cl\u00ednica en etapa avanzada que desarrolla terapias gen\u00e9ticas para enfermedades degenerativas de la retina, anunci\u00f3 hoy una productiva reuni\u00f3n de la FDA para su programa cl\u00ednico que eval\u00faa MCO-010 para el tratamiento de la retinitis pigmentosa (RP). Con base en los comentarios regulatorios proporcionados en la reuni\u00f3n, Nanoscope comenzar\u00e1 con la presentaci\u00f3n de una Solicitud de Licencia Biol\u00f3gica (BLA) en el primer trimestre de 2025.<\/p>\n<p>En el marco de la reuni\u00f3n, la FDA reconoci\u00f3 los pasos propuestos por Nanoscope para facilitar la presentaci\u00f3n de la solicitud de licencia biol\u00f3gica (BLA) para MCO-010 para el tratamiento de la p\u00e9rdida grave de visi\u00f3n debida a la retinosis pigmentaria (RP). Nanoscope detall\u00f3 sus planes para la presentaci\u00f3n escalonada de la BLA de MCO-010 para el tratamiento de la p\u00e9rdida grave de visi\u00f3n debida a la RP, en virtud de su designaci\u00f3n de v\u00eda r\u00e1pida.<\/p>\n<p>La p\u00e9rdida grave de la visi\u00f3n es a menudo el resultado de las personas diagnosticadas con RP, que en \u00faltima instancia conduce a la ceguera. El paradigma de tratamiento actual se centra en la rehabilitaci\u00f3n de la visi\u00f3n, pero los pacientes a\u00fan sufren toda una vida de deterioro progresivo de la visi\u00f3n, lo que afecta dr\u00e1sticamente a su calidad de vida.<\/p>\n<p>\u201cLa preservaci\u00f3n de la agudeza visual basal durante varios a\u00f1os representa un importante efecto del tratamiento que se desv\u00eda de la historia natural esperada de la retinosis pigmentaria\u201d, afirm\u00f3.\u00a0<span class=\"xn-person\">Allen C.Ho<\/span>, MD, FACS, FASRS, Director de Investigaci\u00f3n de Retina y Codirector del Servicio de Retina del Wills Eye Hospital, y Asesor M\u00e9dico Jefe de Nanoscope. \u201cLos comentarios de la FDA han servido de base para el plan de presentaci\u00f3n de la solicitud de licencia biol\u00f3gica (BLA) de Nanoscope, lo que ofrece la posibilidad de una opci\u00f3n viable y restauradora para pacientes cuya visi\u00f3n se ha perdido debido a la variedad de degeneraciones retinianas progresivas que componen la retinosis pigmentaria (RP)\u201d.\u201d<\/p>\n<p>\u201cEstamos satisfechos con las interacciones positivas que hemos tenido con la FDA como resultado de la excepcional experiencia y el incansable compromiso del equipo de Nanoscope\u201d, dijo\u00a0<span class=\"xn-person\">Sulagna Bhattacharya<\/span>, Cofundador y director ejecutivo de Nanoscope. \u201cNuestro objetivo com\u00fan es transformar vidas y, juntos, hemos avanzado con MCO-010 hasta la presentaci\u00f3n de la solicitud de licencia biol\u00f3gica (BLA). Con cada paso que damos, nos centramos en los pacientes que esperan una recuperaci\u00f3n significativa de la visi\u00f3n. Nuestro equipo espera continuar el importante trabajo que hemos iniciado, junto con nuestros socios, para brindar esta terapia a pacientes con necesidades importantes no cubiertas\u201d.\u201d<\/p>\n<p>\u201cEsta productiva reuni\u00f3n con la FDA tambi\u00e9n se produce tras nuestra reciente reuni\u00f3n de fin de fase 2 para nuestro programa de degeneraci\u00f3n macular de Stargardt, que est\u00e1 avanzando a un ensayo de registro de fase 3\u201d, dijo\u00a0<span class=\"xn-person\">Samarendra Mohanty<\/span>, Ph.D., Presidente y Director Cient\u00edfico de Nanoscope. \u201cLa evidencia de mejoras en la agudeza visual a lo largo de 3 a\u00f1os en los estudios RESTORE y REMAIN refuerza nuestro firme compromiso de brindar esta terapia transformadora a los pacientes\u201d.\u201d<\/p>\n<p><b>Acerca de la retinosis pigmentaria<br class=\"dnr\" \/><\/b>La retinosis pigmentaria es un grupo de enfermedades oculares raras que afectan la retina, que presentan s\u00edntomas en la infancia y es una de las principales causas de ceguera en adultos en edad laboral. Es una enfermedad hereditaria, lo que significa que se transmite a los hijos a trav\u00e9s de genes defectuosos de sus padres. Se han identificado m\u00e1s de varios cientos de mutaciones gen\u00e9ticas que pueden causar retinosis pigmentaria. En los pacientes con retinosis pigmentaria, las c\u00e9lulas fotorreceptoras sensibles a la luz se degradan, lo que provoca la p\u00e9rdida de visi\u00f3n. Actualmente, no existen tratamientos aprobados para la p\u00e9rdida grave de la visi\u00f3n debido a la retinosis pigmentaria. Retrasar o prevenir un mayor deterioro de la visi\u00f3n en los pacientes con retinosis pigmentaria es un objetivo del tratamiento.<\/p>\n<p><b>Acerca de MCO-010<br class=\"dnr\" \/><\/b>MCO-010 (<i>sonpiretigene isteparvovec<\/i>, suspensi\u00f3n para inyecci\u00f3n intrav\u00edtrea) es la \u00fanica opsina de banda ancha, r\u00e1pida y m\u00e1s sensible que actualmente se encuentra en ensayos cl\u00ednicos. Las terapias gen\u00e9ticas actuales est\u00e1n dirigidas a tratar a pacientes con mutaciones gen\u00e9ticas espec\u00edficas en las c\u00e9lulas externas de la retina, mientras que la monoterapia optogen\u00e9tica MCO activable con luz ambiental dirigida a abundantes neuronas internas de la retina tiene el potencial de restaurar la p\u00e9rdida de visi\u00f3n debido a RP avanzada, con c\u00e9lulas externas de la retina degeneradas. Con la orientaci\u00f3n a c\u00e9lulas bipolares a trav\u00e9s del promotor-potenciador 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 AAV2 patentado permite una transducci\u00f3n robusta de MCO-010 en c\u00e9lulas bipolares tras inyecci\u00f3n intrav\u00edtrea. El ensayo de fase 1\/2 de MCO-010 en pacientes con RP avanzada demostr\u00f3 una mejora en la movilidad guiada por la visi\u00f3n, la discriminaci\u00f3n de formas y la agudeza visual. Una proporci\u00f3n significativa de pacientes tratados con MCO-010 en el ensayo multic\u00e9ntrico aleatorizado doble ciego RESTORE exhibieron mejoras en la agudeza visual mejor corregida, as\u00ed como en la visi\u00f3n funcional evaluada mediante movilidad guiada por la visi\u00f3n y discriminaci\u00f3n de formas, junto con un perfil de seguridad favorable.<\/p>\n<p><b>Otras actualizaciones cl\u00ednicas<br class=\"dnr\" \/><\/b>La empresa ha completado el ensayo STARLIGHT de fase 2 de la terapia MCO-010 en pacientes con Stargardt (<a href=\"https:\/\/clinicaltrials.gov\/study\/NCT05417126\" target=\"_blank\" rel=\"nofollow noopener\">NCT05417126<\/a>) y recientemente\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\">anunci\u00f3 planes para iniciar una Fase 3<\/a>\u00a0ensayo de registro en el primer trimestre de 2025.<\/p>\n<p><b>Acerca de Nanoscope Therapeutics, Inc.<br class=\"dnr\" \/><\/b>Nanoscope Therapeutics est\u00e1 desarrollando terapias optogen\u00e9ticas independientes del gen y que restauran la visi\u00f3n para los millones de pacientes ciegos por enfermedades degenerativas de la retina, para las cuales no existe cura. El principal activo de la compa\u00f1\u00eda, MCO-010, inform\u00f3 recientemente los resultados preliminares del ensayo cl\u00ednico multic\u00e9ntrico, aleatorizado, doble ciego y controlado con placebo RESTORE Fase 2b en los EE. UU. para la retinosis pigmentaria (<a href=\"https:\/\/clinicaltrials.gov\/study\/NCT04945772\" target=\"_blank\" rel=\"nofollow noopener\">NCT04945772<\/a>). MCO-010 ha recibido designaciones de v\u00eda r\u00e1pida de la FDA y de medicamento hu\u00e9rfano de la FDA tanto para RP como para 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<\/div>\n<\/div>\n<\/section>\n<\/article>","protected":false},"excerpt":{"rendered":"<p>Productive FDA meeting\u00a0paves the way for BLA submission for MCO-010 in Q1 2025 DALLAS, TX \u2014 Oct. 10, 2024\u00a0 \u2014 Nanoscope Therapeutics Inc., a late-stage clinical biotechnology company developing gene therapies for retinal degenerative diseases today announced a productive FDA meeting for its clinical program evaluating MCO-010 for the treatment of retinitis pigmentosa (RP). Based [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":5827,"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-5822","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 Announces Plans to Submit BLA for MCO-010 to Treat 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\/10\/10\/nanoscope-announces-plans-to-submit-bla-for-mco-010-to-treat-retinitis-pigmentosa\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nanoscope Announces Plans to Submit BLA for MCO-010 to Treat 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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