{"id":9121,"date":"2025-07-14T06:06:03","date_gmt":"2025-07-14T11:06:03","guid":{"rendered":"https:\/\/nanostherapeutics.com\/?p=9121"},"modified":"2025-07-23T18:39:41","modified_gmt":"2025-07-23T23:39:41","slug":"nanoscope-therapeutics-initiates-rolling-submission-of-biologics-license-application-to-fda-for-mco-010-the-first-gene-agnostic-therapy-to-treat-retinitis-pigmentosa","status":"publish","type":"post","link":"https:\/\/nanostherapeutics.com\/es\/2025\/07\/14\/nanoscope-therapeutics-initiates-rolling-submission-of-biologics-license-application-to-fda-for-mco-010-the-first-gene-agnostic-therapy-to-treat-retinitis-pigmentosa\/","title":{"rendered":"Nanoscope Therapeutics inicia la presentaci\u00f3n escalonada de la solicitud de licencia de productos biol\u00f3gicos ante la FDA para MCO-010, la primera terapia gen\u00e9ticamente independiente para tratar la retinosis pigmentaria."},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"9121\" class=\"elementor elementor-9121\" 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<ul><li><h3><em>Los primeros m\u00f3dulos de la solicitud de licencia biol\u00f3gica (BLA) se presentaron a la FDA bajo revisi\u00f3n continua, y se prev\u00e9 la presentaci\u00f3n completa a principios de 2026.<\/em><\/h3><\/li><li><h3><em>La solicitud de licencia biol\u00f3gica MCO-010 para la retinosis pigmentaria es elegible para revisi\u00f3n prioritaria en base a la designaci\u00f3n de v\u00eda r\u00e1pida.<\/em><\/h3><\/li><li><h3><em>De ser aprobado, MCO-010 tiene el potencial de convertirse en el tratamiento est\u00e1ndar para la retinosis pigmentaria, administrado mediante una inyecci\u00f3n intrav\u00edtrea \u00fanica en el consultorio, con la capacidad de restaurar la visi\u00f3n en pacientes con p\u00e9rdida visual grave, independientemente de su mutaci\u00f3n gen\u00e9tica subyacente.<\/em><\/h3><\/li><\/ul><div class=\"col-sm-4 col-xs-12 col-vcenter\"><div class=\"image logo logo-wrapper\" data-src=\"https:\/\/mma.prnewswire.com\/media\/1333752\/Nanoscope_Therapeutics_Logo.jpg?p=publish\" data-asset-type=\"photo\" data-asset-label=\"Logo\" data-download-url=\"https:\/\/mma.prnewswire.com\/media\/1333752\/Nanoscope_Therapeutics_Logo.jpg\" data-tweet-text=\"Nanoscope Therapeutics Logo (PRNewsfoto\/Nanoscope Therapeutics)\" data-pinterest-text=\"Nanoscope Therapeutics Logo (PRNewsfoto\/Nanoscope Therapeutics)\" data-linkedin-text=\"Nanoscope Therapeutics Logo (PRNewsfoto\/Nanoscope Therapeutics)\" data-facebook-share-text=\"Nanoscope Therapeutics Logo (PRNewsfoto\/Nanoscope Therapeutics)\" data-twitter-share-url=\"https:\/\/mma.prnewswire.com\/media\/1333752\/Nanoscope_Therapeutics_Logo.jpg?p=twitter\" data-facebook-share-url=\"https:\/\/mma.prnewswire.com\/media\/1333752\/Nanoscope_Therapeutics_Logo.jpg?p=facebook\" data-pinterest-share-url=\"https:\/\/mma.prnewswire.com\/media\/1333752\/Nanoscope_Therapeutics_Logo.jpg?p=publish\" data-linkedin-share-url=\"https:\/\/mma.prnewswire.com\/media\/1333752\/Nanoscope_Therapeutics_Logo.jpg?p=linkedin\"><p><strong>DALLAS, TX, 14 de julio de 2025<\/strong>\u00a0\u2013\u00a0<a href=\"https:\/\/nanostherapeutics.com\/es\/\"><strong>Nanoscope Therapeutics Inc.,<\/strong><\/a> Una empresa de biotecnolog\u00eda comprometida con el desarrollo y la comercializaci\u00f3n de terapias novedosas e independientes de genes para pacientes que sufren una p\u00e9rdida grave de la visi\u00f3n debido a enfermedades degenerativas de la retina, anunci\u00f3 hoy el inicio de la presentaci\u00f3n escalonada de una Solicitud de Licencia para Productos Biol\u00f3gicos (BLA, por sus siglas en ingl\u00e9s) ante la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en ingl\u00e9s) para su principal terapia en investigaci\u00f3n, MCO-010, para el tratamiento de la p\u00e9rdida grave de la visi\u00f3n debido a la retinosis pigmentaria (RP).<\/p><p>Esto marca un hito regulatorio significativo ya que <strong>primera BLA presentada para un gen independiente<\/strong><strong> gene<\/strong><strong> terapia<\/strong><strong> para enfermedades de la retina<\/strong>. El hecho de ser independiente de los genes significa que MCO-010 est\u00e1 dise\u00f1ado para abordar la amplia diversidad gen\u00e9tica de la retinosis pigmentaria (RP), una afecci\u00f3n vinculada a m\u00e1s de 100 genes conocidos y m\u00e1s de 1000 mutaciones diferentes.<strong>independientemente de la mutaci\u00f3n subyacente<\/strong>.<\/p><p>La FDA ha concedido a Nanoscope una revisi\u00f3n continua de su solicitud de licencia biol\u00f3gica (BLA), cuyos primeros m\u00f3dulos ya se han presentado y cuya presentaci\u00f3n completa se prev\u00e9 para principios de 2026. La solicitud cumple los requisitos para una revisi\u00f3n prioritaria en el marco del programa de v\u00eda r\u00e1pida.<\/p><p><strong>De ser aprobada, MCO-010 ser\u00eda la primera terapia independiente del gen que restaurar\u00eda la visi\u00f3n en pacientes con retinosis pigmentaria legalmente ciegos.<\/strong>, lo que podr\u00eda brindar una importante oportunidad de mercado y, lo que es m\u00e1s importante, establecer el est\u00e1ndar de atenci\u00f3n para los pacientes que sufren discapacidad visual debido a la retinosis pigmentaria.<\/p><p>\u201cPor primera vez, los pacientes que se consideran en v\u00edas de ceguera permanente pueden tener la oportunidad de recuperar la vista\u201d, dijo.\u00a0<a href=\"https:\/\/nanostherapeutics.com\/es\/who-we-are\/sulagna-bhattcharya\/\">Sulagna Bhattacharya, CEO y cofundadora de Nanoscope.<\/a>. \u201cEstamos profundamente agradecidos a la FDA por su orientaci\u00f3n, ya que nos mantenemos firmes en nuestra misi\u00f3n de restaurar la visi\u00f3n y devolver la luz a la vida de quienes viven en la oscuridad.\u201d<\/p><p>MCO-010, la opsina multicaracter\u00edstica (MCO) patentada por Nanoscope, se administra mediante una inyecci\u00f3n intrav\u00edtrea \u00fanica en la consulta. Tras la inyecci\u00f3n, MCO-010 activa las c\u00e9lulas bipolares de la retina, altamente densas, para que se vuelvan sensibles a la luz, utilizando los circuitos visuales restantes tras la muerte de los fotorreceptores. MCO-010 est\u00e1 dise\u00f1ado para ofrecer un enfoque diferente, ya que no requiere pruebas gen\u00e9ticas, intervenci\u00f3n quir\u00fargica ni dosis repetidas, lo que lo hace aplicable a una amplia poblaci\u00f3n de pacientes con retinosis pigmentaria, a la vez que se integra en los flujos de trabajo habituales en las consultas de retina.<\/p><p>\u201cHemos estado trabajando en la plataforma MCO durante m\u00e1s de una d\u00e9cada\u201d, a\u00f1adi\u00f3.\u00a0<a href=\"https:\/\/nanostherapeutics.com\/es\/who-we-are\/samarendra-mohanty\/\">Samarendra Mohanty, PhD, Presidente, Director Cient\u00edfico y Cofundador de Nanoscope.<\/a>. \u201cHemos visto que esta terapia experimental ha superado nuestras expectativas tanto en el laboratorio como en pacientes que participan en ensayos cl\u00ednicos, y creemos que ahora estamos un paso m\u00e1s cerca de poder ofrecer esta terapia pionera a todos los pacientes con retinosis pigmentaria.\u201d<\/p><p>La retinosis pigmentaria (RP) es una de las principales causas de ceguera en la poblaci\u00f3n en edad laboral en los Estados Unidos, afectando a m\u00e1s de 100 000 personas y dejando a m\u00e1s de 25 000 legalmente ciegas. La p\u00e9rdida de visi\u00f3n debido a la RP depende en gran medida de la mutaci\u00f3n subyacente presente y, en promedio, los pacientes con RP pierden una l\u00ednea de visi\u00f3n en una tabla optom\u00e9trica aproximadamente cada tres a\u00f1os, y la mayor\u00eda son legalmente ciegos (visi\u00f3n peor que 20\/200) a los 60 a\u00f1os.<\/p><p>\u201cUno de los aspectos m\u00e1s desafiantes de toda mi carrera ha sido decirles a los pacientes con retinosis pigmentaria que no existe un tratamiento restaurador disponible, ya que experimentan una p\u00e9rdida de visi\u00f3n progresiva, irreversible y permanente\u201d, dijo. <a href=\"https:\/\/nanostherapeutics.com\/es\/who-we-are\/allen-ho-vac\/\">El Dr. Allen C. Ho, MD, Director de Investigaci\u00f3n de Retina en el Wills Eye Hospital y Asesor M\u00e9dico Jefe de Nanoscope.<\/a>. \u201cBas\u00e1ndose en la ciencia precl\u00ednica y la evidencia de los ensayos cl\u00ednicos, MCO-010 representa un posible e importante cambio de paradigma para los pacientes y los especialistas en retina, ofreciendo la esperanza de una mejora significativa en la calidad de vida de los pacientes con problemas de retina m\u00e1s necesitados.\u201d<\/p><p>En el ensayo pivotal RESTORE de fase 2b de Nanoscope, MCO-010 alcanz\u00f3 sus objetivos primarios de agudeza visual corregida en ambos grupos de dosis a las 52 semanas en comparaci\u00f3n con el grupo de control simulado, con mejoras visuales respecto al valor basal de &gt;0,3 LogMAR, un resultado equivalente a tres o m\u00e1s l\u00edneas en una tabla optom\u00e9trica. En el seguimiento a largo plazo en curso, se observaron mejoras en la agudeza visual durante 3 a\u00f1os, sin que se notificaran eventos adversos graves en los ojos tratados. Se ha programado un seguimiento plurianual adicional con estos pacientes para evaluar la eficacia y la seguridad a largo plazo.<\/p><p>\u201cEs la primera vez que la FDA evaluar\u00e1 una solicitud para una terapia gen\u00e9tica independiente para una enfermedad retiniana hereditaria\u201d, concluy\u00f3. <a href=\"https:\/\/nanostherapeutics.com\/es\/who-we-are\/glenn-sblendorio-bod\/\">Glenn Sblendorio, Presidente del Consejo de Administraci\u00f3n de Nanoscope<\/a>. \u201cConfiamos en nuestros datos cl\u00ednicos, que creemos marcar\u00e1n el comienzo de una nueva era en el cuidado de la retina. Nuestro objetivo es devolver la esperanza a los pacientes con retinosis pigmentaria y, eventualmente, a muchos otros pacientes con enfermedades degenerativas de la retina.\u201d \u00a0<\/p><p>Para obtener m\u00e1s informaci\u00f3n sobre MCO-010 y Nanoscope Therapeutics, visite: <a href=\"https:\/\/url.avanan.click\/v2\/___https:\/www.nanostherapeutics.com___.YXAzOm5hbm9zY29wZXRoZXJhcGV1dGljczphOm86ODBiMzBmNTQ3ZmEyNzYzOWY5NDk5ODg3OWY5NDBlOTQ6Njo0YmI4OjlmOTc0YTdjYzdjMmFlZTQ3YTY5MDhkMmYxZTllZThiYWY4MzU4ZDI1YzMyMWViMTIyMWQ2YzViNWNjMjZhNTA6cDpUOk4\">www.nanostherapeutics.com<\/a>.<\/p><p><strong>Acerca de Nanoscope Therapeutics<\/strong><\/p><p>Nanoscope Therapeutics est\u00e1 desarrollando una terapia optogen\u00e9tica independiente del gen que restaura la visi\u00f3n 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 para la retinosis pigmentaria (RP) (<a href=\"https:\/\/url.avanan.click\/v2\/___https:\/clinicaltrials.gov\/study\/NCT04945772___.YXAzOm5hbm9zY29wZXRoZXJhcGV1dGljczphOm86ODBiMzBmNTQ3ZmEyNzYzOWY5NDk5ODg3OWY5NDBlOTQ6Njo0YWVjOmU5YTIyOGNiZDRhMzQ3NzJkNWE0NDg0MjliN2JlZjMxN2Q1ZmM4NWU2MTBiOWQwNjZkM2ZjZDZkMGQ5NjVjMWI6cDpUOk4\">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:\/\/url.avanan.click\/v2\/___https:\/clinicaltrials.gov\/study\/NCT05417126___.YXAzOm5hbm9zY29wZXRoZXJhcGV1dGljczphOm86ODBiMzBmNTQ3ZmEyNzYzOWY5NDk5ODg3OWY5NDBlOTQ6NjpjMWRkOmVmOTBkMjllMDdkZTAwZGRhNmY0NGIxZWVmYzExOWI2OWU5ZGY3YTRjYTQ5ZTMyZjZlOTQxYTJjOGZkMjM4YmM6cDpUOk4\">NCT05417126<\/a>) y planea iniciar una <a href=\"https:\/\/url.avanan.click\/v2\/___https:\/nanostherapeutics.com\/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\/___.YXAzOm5hbm9zY29wZXRoZXJhcGV1dGljczphOm86ODBiMzBmNTQ3ZmEyNzYzOWY5NDk5ODg3OWY5NDBlOTQ6NjoxM2E1OjdmZGE1NmRiYjg5MmIyYzAzOGRlYzc4YWY3ZmRlZmNmMjhlZjNkZmQ2Y2Y0MTE1ZWQ2MzMwMDg1MTAwMDAwYzk6cDpUOk4\">Ensayo de registro de fase 3<\/a> En 2025, MCO-010 recibi\u00f3 las designaciones de v\u00eda r\u00e1pida y medicamento hu\u00e9rfano de la FDA para RP y SD. Los programas precl\u00ednicos incluyen amaurosis cong\u00e9nita de Leber (LCA), en estudios precl\u00ednicos, as\u00ed como un f\u00e1rmaco listo para la solicitud de IND para atrofia geogr\u00e1fica (GA).\u00a0<\/p><p><strong>Contacto:<\/strong><\/p><p>Terap\u00e9utica del nanoscopio<br \/>(817) 857-1186<br \/>PR@nanostherapeutics.com<\/p><\/div><\/div>\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>First modules of BLA submitted to FDA under rolling review, with full submission anticipated in early 2026 MCO-010 BLA for retinitis pigmentosa is eligible for priority review based on fast-track designation If approved, MCO-010 has the potential to be the standard of care for retinitis pigmentosa, delivered via a one-time, in-office intravitreal injection with the [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":9185,"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-9121","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 Initiates Rolling Submission of Biologics License Application to FDA for MCO-010, the First Gene-Agnostic Therapy 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\/2025\/07\/14\/nanoscope-therapeutics-initiates-rolling-submission-of-biologics-license-application-to-fda-for-mco-010-the-first-gene-agnostic-therapy-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 Therapeutics Initiates Rolling Submission of Biologics License Application to FDA for MCO-010, the First Gene-Agnostic Therapy 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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