{"id":9454,"date":"2025-09-02T06:25:37","date_gmt":"2025-09-02T11:25:37","guid":{"rendered":"https:\/\/nanostherapeutics.com\/?p=9454"},"modified":"2025-10-13T06:34:02","modified_gmt":"2025-10-13T11:34:02","slug":"nanoscope-strengthens-global-regulatory-pathways-for-mco-010-with-fda-rmat-and-five-ema-orphan-designations","status":"publish","type":"post","link":"https:\/\/nanostherapeutics.com\/es\/2025\/09\/02\/nanoscope-strengthens-global-regulatory-pathways-for-mco-010-with-fda-rmat-and-five-ema-orphan-designations\/","title":{"rendered":"Nanoscope refuerza las v\u00edas regulatorias globales para MCO-010 con la designaci\u00f3n RMAT de la FDA y cinco designaciones de medicamento hu\u00e9rfano de la EMA."},"content":{"rendered":"
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La Agencia Europea de Medicamentos otorga a MCO-010 cinco designaciones de medicamento hu\u00e9rfano para un amplio espectro de enfermedades de la retina que implican la p\u00e9rdida de fotorreceptores, incluidas las distrofias sindr\u00f3micas y no sindr\u00f3micas, las que afectan principalmente a los bastones y a los conos, y las distrofias maculares.<\/i><\/h3>

La FDA otorga a MCO-010 la designaci\u00f3n de Terapia Avanzada de Medicina Regenerativa (RMAT, por sus siglas en ingl\u00e9s), adem\u00e1s de las designaciones actuales de Medicamento Hu\u00e9rfano y V\u00eda R\u00e1pida, para la enfermedad de Stargardt.<\/i><\/h3>

Nanoscope est\u00e1 redefiniendo el est\u00e1ndar de atenci\u00f3n para las degeneraciones retinianas con necesidades no cubiertas importantes gracias a su plataforma optogen\u00e9tica MCO-010, que no depende de la enfermedad.<\/i><\/h3><\/div><\/div><\/section>

DALLAS<\/span><\/span>,\u00a02 de septiembre de 2025<\/span><\/span>\u00a0\u2014\u00a0Nanoscopio Therapeutics Inc.<\/a>, MCO-010 (sonpiretigene isteparvovec), una empresa de biotecnolog\u00eda dedicada al desarrollo y la comercializaci\u00f3n de terapias novedosas para pacientes con p\u00e9rdida de fotorreceptores y discapacidad visual por degeneraci\u00f3n retiniana, anunci\u00f3 hoy que la Agencia Europea de Medicamentos (EMA) ha otorgado la designaci\u00f3n de medicamento hu\u00e9rfano a MCO-010 para cinco categor\u00edas de distrofias retinianas. Adem\u00e1s, la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) ha otorgado la designaci\u00f3n RMAT a MCO-010 para la enfermedad de Stargardt.<\/p>

Las designaciones de medicamento hu\u00e9rfano de la EMA abarcan las distrofias no sindr\u00f3micas y sindr\u00f3micas con predominio de bastones y conos, as\u00ed como las distrofias maculares, lo que proporciona una posible v\u00eda regulatoria independiente de la enfermedad para docenas de afecciones retinianas. La nueva designaci\u00f3n RMAT de la FDA para la distrofia espinosa de Duchenne (SD) se basa en las designaciones previas de medicamento hu\u00e9rfano y v\u00eda r\u00e1pida para la retinosis pigmentaria (RP) y la SD. Las acciones de la EMA y la FDA subrayan el reconocimiento de las agencias reguladoras del potencial de MCO-010 para abordar necesidades importantes no cubiertas en las enfermedades degenerativas de la retina.<\/p>

\u201cObtener la designaci\u00f3n RMAT para la enfermedad de Stargardt, adem\u00e1s de nuestras designaciones previas de la FDA para la enfermedad de Stargardt y la retinosis pigmentaria, es una validaci\u00f3n importante para nuestras terapias que justifica un desarrollo y una revisi\u00f3n acelerados\u201d, dijo.\u00a0Sulagna Bhattacharya<\/span>, CEO de Nanoscope. \u201cEn combinaci\u00f3n con las cinco designaciones de medicamento hu\u00e9rfano de la EMA, estos logros destacan el impulso global que respalda nuestra plataforma MCO como una posible terapia para restaurar la visi\u00f3n en pacientes con pocas o ninguna opci\u00f3n de tratamiento\u201d.\u201d<\/p>

MCO (opsina multicaracter\u00edstica) es una plataforma terap\u00e9utica intrav\u00edtrea de dosis \u00fanica, administrada en consulta, y aplicable a cualquier enfermedad, dise\u00f1ada para restaurar la visi\u00f3n en pacientes con degeneraci\u00f3n de fotorreceptores, incluyendo retinosis pigmentaria (RP), degeneraci\u00f3n seborreica (DS) 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. MCO no requiere pruebas gen\u00e9ticas, intervenci\u00f3n quir\u00fargica ni dosis repetidas, lo que permite una amplia aplicabilidad en pacientes dentro de los flujos de trabajo habituales en las consultas de retina.<\/p>

Los programas cl\u00ednicos de Nanoscope para mejorar la visi\u00f3n est\u00e1n avanzando a nivel mundial, con resultados positivos en la Fase\u00a02b<\/span>Resultados del ensayo RESTORE \/3 en RP y hallazgos alentadores del ensayo STARLIGHT de fase 2 en SD. Se espera que un ensayo de registro de fase 3 en SD y un ensayo de fase 2 en GA comiencen a finales de 2025.<\/p>

Las enfermedades degenerativas de la retina, incluidas la retinosis pigmentaria (RP), la degeneraci\u00f3n macular (SD), las distrofias maculares y los s\u00edndromes retinianos, afectan a millones de pacientes en todo el mundo. Estas enfermedades alteran la vida, son cr\u00f3nicamente debilitantes y carecen de opciones de tratamiento ampliamente efectivas. En la Uni\u00f3n Europea, la designaci\u00f3n de medicamento hu\u00e9rfano por la EMA ofrece oportunidades para la asistencia en el protocolo y hasta 10 a\u00f1os de exclusividad de mercado tras la aprobaci\u00f3n.\u00a0los Estados Unidos<\/span>, Las designaciones Orphan, Fast Track y RMAT ofrecen oportunidades para un desarrollo y revisi\u00f3n acelerados, flexibilidad en el dise\u00f1o de los ensayos y siete a\u00f1os de exclusividad de mercado tras su aprobaci\u00f3n.<\/p>

Acerca de Nanoscope Therapeutics<\/b><\/p>

Nanoscope Therapeutics est\u00e1 desarrollando una terapia optogen\u00e9tica para restaurar la visi\u00f3n, aplicable a cualquier enfermedad, para millones de pacientes ciegos por enfermedades degenerativas de la retina. Tras los resultados positivos de la fase RESTORE\u00a02b<\/span>\/3 Ensayo cl\u00ednico multic\u00e9ntrico, aleatorizado, doble ciego y controlado con placebo para la retinosis pigmentaria (RP) (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) (NCT05417126<\/a>) y planea iniciar una\u00a0Ensayo de registro de fase 3<\/a>\u00a0En 2025, 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 finales de 2025. Otros programas listos para IND incluyen la amaurosis cong\u00e9nita de Leber (LCA).<\/p>

Contacto:
<\/b>Terap\u00e9utica del nanoscopio
(817) 857-1186
PR@nanostherapeutics.com<\/a><\/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":"

European Medicines Agency grants MCO-010 five Orphan designations across a wide spectrum of retinal diseases involving photoreceptor loss, including syndromic and non-syndromic, rod- and cone-dominant, and macular dystrophies. FDA grants MCO-010 Regenerative Medicine Advanced Therapy (RMAT) designation, in addition to current Orphan Drug and Fast Track designations, for Stargardt disease. Nanoscope is redefining the standard […]<\/p>\n","protected":false},"author":6,"featured_media":8971,"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-9454","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-home-page","category-nanoscope-press-release"],"yoast_head":"\nNanoscope Strengthens Global Regulatory Pathways for MCO-010 with FDA RMAT and Five EMA Orphan Designations - 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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