{"id":10293,"date":"2026-09-09T06:06:11","date_gmt":"2026-09-09T11:06:11","guid":{"rendered":"https:\/\/nanostherapeutics.com\/?p=10293"},"modified":"2026-09-09T06:25:48","modified_gmt":"2026-09-09T11:25:48","slug":"nanoscope-therapeutics-announces-u-s-food-and-drug-administration-acceptance-of-biologics-license-application-for-mogenry-for-the-treatment-of-retinitis-pigmentosa-with-severe-vision-loss","status":"publish","type":"post","link":"https:\/\/nanostherapeutics.com\/es\/2026\/09\/09\/nanoscope-therapeutics-announces-u-s-food-and-drug-administration-acceptance-of-biologics-license-application-for-mogenry-for-the-treatment-of-retinitis-pigmentosa-with-severe-vision-loss\/","title":{"rendered":"Nanoscope Therapeutics anuncia que la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) ha aceptado la solicitud de licencia para productos biol\u00f3gicos de MOGENRY para el tratamiento de la retinosis pigmentaria con p\u00e9rdida grave de la visi\u00f3n."},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"10293\" class=\"elementor elementor-10293\" 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><i>De aprobarse, MOGENRY ser\u00eda el primer tratamiento independiente del gen disponible para pacientes con retinosis pigmentaria que sufren una p\u00e9rdida grave de visi\u00f3n.<\/i><\/li><li><i>La solicitud de licencia biol\u00f3gica (BLA) est\u00e1 respaldada por los datos positivos de la fase 2b\/3 del estudio RESTORE y los datos de seguimiento a largo plazo del estudio REMAIN.<\/i><\/li><\/ul><p><span class=\"legendSpanClass\">DALLAS<\/span>,\u00a0<span class=\"legendSpanClass\">9 de septiembre de 2026<\/span>\u00a0\u2014\u00a0<a href=\"http:\/\/nanostherapeutics.com\/es\/\" target=\"_blank\" rel=\"nofollow noopener\">Terap\u00e9utica del nanoscopio<\/a>, Nanoscope, Inc. (\u201cNanoscope\u201d), una empresa de biotecnolog\u00eda centrada en 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 la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) ha aceptado y presentado la Solicitud de Licencia de Productos Biol\u00f3gicos (BLA) que busca la aprobaci\u00f3n de\u00a0<b>MOGENRY<\/b><b><sup>\u00ae<\/sup><\/b><b>\u00a0(sonpiretigene isteparvovec, MCO-010)<\/b>, una terapia g\u00e9nica optogen\u00e9tica dise\u00f1ada para la restauraci\u00f3n de la visi\u00f3n en pacientes con retinosis pigmentaria (RP) que presentan una p\u00e9rdida de visi\u00f3n grave.<\/p><p>\u201cLa aceptaci\u00f3n por parte de la FDA y la presentaci\u00f3n de nuestra solicitud de licencia biol\u00f3gica (BLA) para MOGENRY representan un hito crucial que nos acerca un paso fundamental a ofrecer una opci\u00f3n de tratamiento \u00fanico y ambulatorio a la comunidad de pacientes con retinosis pigmentaria y p\u00e9rdida grave de visi\u00f3n, quienes actualmente no cuentan con una terapia aprobada\u201d, declar\u00f3 Sulagna Bhattacharya, directora ejecutiva de Nanoscope Therapeutics. \u201cLa solidez de los datos de nuestro estudio RESTORE, junto con la durabilidad observada durante el seguimiento a largo plazo en el estudio REMAIN, nos da confianza en el potencial de MOGENRY para convertirse en un nuevo est\u00e1ndar de atenci\u00f3n para pacientes con retinosis pigmentaria y p\u00e9rdida grave de visi\u00f3n. Esperamos colaborar estrechamente con la FDA durante todo el proceso de revisi\u00f3n\u201d.\u201d<\/p><p>La BLA est\u00e1 respaldada por datos positivos de eficacia y seguridad del ensayo de fase 1\/2a (<a href=\"https:\/\/clinicaltrials.gov\/study\/NCT04919473\" target=\"_blank\" rel=\"nofollow noopener\">NCT04919473<\/a>), y el ensayo cl\u00ednico multic\u00e9ntrico, aleatorizado, doble ciego y controlado con placebo RESTORE Fase 2b\/3 (<a href=\"https:\/\/clinicaltrials.gov\/study\/NCT04945772\" target=\"_blank\" rel=\"nofollow noopener\">NCT04945772<\/a>). RESTORE cumpli\u00f3 sus objetivos primarios y secundarios clave, demostrando mejoras en la agudeza visual en las semanas 52 y 76. MOGENRY fue bien tolerado, sin que se notificaran eventos adversos graves relacionados con el tratamiento.<\/p><p>\u201cRestaurar la visi\u00f3n es el objetivo m\u00e1s dif\u00edcil de alcanzar en la terapia g\u00e9nica oft\u00e1lmica, y MOGENRY parece estar superando ese obst\u00e1culo, con a\u00f1os de mejor\u00eda visual. Esta combinaci\u00f3n convierte este momento en un hito, no solo para nuestros pacientes con una necesidad no cubierta y para Nanoscope, sino para todo nuestro campo. MOGENRY no requiere pruebas gen\u00e9ticas ni administraci\u00f3n en un quir\u00f3fano, lo que podr\u00eda facilitar su adopci\u00f3n generalizada por parte de las consultas de retina comunitarias. De ser aprobado, MOGENRY podr\u00eda inaugurar una nueva era en el tratamiento de la retinosis pigmentaria al alcance de pacientes que no tienen acceso a un centro acad\u00e9mico de tercer nivel\u201d, afirm\u00f3 Allen C. Ho, MD, profesor de Oftalmolog\u00eda de la Universidad Thomas Jefferson, director de Investigaci\u00f3n de Retina del Wills Eye Hospital y asesor m\u00e9dico principal de Nanoscope Therapeutics.\u00a0<\/p><p>La mayor\u00eda de los pacientes tratados en el estudio RESTORE han continuado participando en el estudio REMAIN, que proporciona datos de seguimiento a largo plazo en la solicitud de licencia biol\u00f3gica (BLA). De ser aprobado, MOGENRY se convertir\u00eda en la primera terapia independiente del gen para mejorar la visi\u00f3n en pacientes con retinosis pigmentaria que presentan una p\u00e9rdida visual grave.<\/p><p>\u201cComo especialistas en retina, hemos visto c\u00f3mo muchos f\u00e1rmacos prometedores no han logrado demostrar, y mucho menos mantener, los beneficios para los pacientes. Lo que distingue a MOGENRY es un beneficio significativo, con evidencia de un efecto sostenido durante a\u00f1os. La durabilidad a largo plazo es precisamente lo que los m\u00e9dicos necesitan ver en un tratamiento \u00fanico y saber que sus pacientes pueden confiar plenamente en \u00e9l\u201d, afirm\u00f3 SriniVas Sadda, MD, titular de la C\u00e1tedra A. Ray Irvine, Jr., MD, Catedr\u00e1tico de Oftalmolog\u00eda Cl\u00ednica y Profesor de la Facultad de Medicina David Geffen de la Universidad de California en Los \u00c1ngeles y del Instituto Oftalmol\u00f3gico Doheny, y Presidente del Comit\u00e9 Asesor Visionario de Nanoscope.<\/p><p><b>Acerca de la retinosis pigmentaria<br class=\"dnr\" \/><\/b>La retinosis pigmentaria (RP) es un grupo de trastornos hereditarios raros en los que las c\u00e9lulas fotorreceptoras se degeneran progresivamente, lo que provoca deterioro de la visi\u00f3n y, finalmente, ceguera. La RP est\u00e1 relacionada con m\u00e1s de 1000 mutaciones en m\u00e1s de 100 genes. Es una de las principales causas de ceguera entre la poblaci\u00f3n en edad laboral en los Estados Unidos, afectando a m\u00e1s de 100\u00a0000 personas, de las cuales m\u00e1s de 25\u00a0000 son legalmente ciegas. La tasa de p\u00e9rdida de visi\u00f3n var\u00eda seg\u00fan la mutaci\u00f3n subyacente, pero los pacientes pierden aproximadamente 0,03 LogMAR (alrededor de 1,5 letras) por a\u00f1o en promedio, lo que equivale aproximadamente a una l\u00ednea de visi\u00f3n en una tabla optom\u00e9trica cada tres a\u00f1os. La mayor\u00eda son legalmente ciegos (con una agudeza visual inferior a 20\/200) a los 60 a\u00f1os.<\/p><p><b>Acerca de MOGENRY (sonpiretigene isteparvovec, MCO-010)<br class=\"dnr\" \/><\/b>La tecnolog\u00eda de opsina multicaracter\u00edstica (MCO) de Nanoscope utiliza una opsina sint\u00e9tica patentada, modificada gen\u00e9ticamente, para optimizar su rendimiento en t\u00e9rminos de alta sensibilidad a la luz en un amplio espectro y una cin\u00e9tica r\u00e1pida. Tras la concepci\u00f3n e invenci\u00f3n de la tecnolog\u00eda por parte de Samarendra Mohanty, cofundador, presidente y director cient\u00edfico de Nanoscope, su equipo ha dedicado m\u00e1s de una d\u00e9cada a evaluar su rendimiento en diversos modelos animales y enfermedades humanas. MOGENRY es una terapia g\u00e9nica optogen\u00e9tica intrav\u00edtrea experimental, de una sola aplicaci\u00f3n y administrada en consulta, basada en la plataforma MCO de Nanoscope. Al administrar un gen de opsina multicaracter\u00edstica a las c\u00e9lulas bipolares de la retina, de alta densidad, MOGENRY confiere a estas c\u00e9lulas supervivientes sensibilidad directa a la luz, permiti\u00e9ndoles utilizar el circuito visual restante tras la p\u00e9rdida de fotorreceptores. MOGENRY no requiere pruebas gen\u00e9ticas, cirug\u00eda invasiva ni dosis repetidas, y est\u00e1 dise\u00f1ado para su administraci\u00f3n 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 (<a href=\"https:\/\/clinicaltrials.gov\/study\/NCT04945772\" target=\"_blank\" rel=\"nofollow noopener\">NCT04945772<\/a>), la FDA ha aceptado y presentado la BLA de la Compa\u00f1\u00eda para MOGENRY. Si se aprueba, MOGENRY tiene el potencial de convertirse en 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 un ensayo de registro de Fase 3 en 2026. MCO-010 ha recibido 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 que cubren distrofias dominantes de bastones y conos no sindr\u00f3micas y sindr\u00f3micas, as\u00ed como distrofias maculares. MCO-010 tambi\u00e9n ha recibido las designaciones de Sakigake y Medicamento Hu\u00e9rfano para distrofias retinianas hereditarias (IRD) en Jap\u00f3n y una designaci\u00f3n de Medicamento Hu\u00e9rfano para IRD en Arabia Saudita. Se espera que un programa de Fase 2 para MCO en atrofia geogr\u00e1fica comience en 2026, y otros programas listos para IND incluyen amaurosis cong\u00e9nita de Leber (LCA).<\/p><p><b>Medios de comunicaci\u00f3n<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>\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>If approved, MOGENRY would be the first gene-agnostic treatment available for patients with retinitis pigmentosa having severe vision loss BLA supported by positive RESTORE Phase 2b\/3 data and REMAIN long-term follow-up data DALLAS,\u00a0Sept. 9, 2026\u00a0&#8212;\u00a0Nanoscope Therapeutics, Inc. (&#8220;Nanoscope&#8221;), a biotechnology company focused on developing and commercializing novel, disease\u2011agnostic therapies for patients with photoreceptor loss and [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":10294,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"footnotes":"","_links_to":"","_links_to_target":""},"categories":[13,8],"tags":[],"class_list":["post-10293","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 v28.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Nanoscope Therapeutics Announces U.S. Food and Drug Administration Acceptance of Biologics License Application for MOGENRY for the Treatment of Retinitis Pigmentosa with Severe Vision Loss - 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\/2026\/09\/09\/nanoscope-therapeutics-announces-u-s-food-and-drug-administration-acceptance-of-biologics-license-application-for-mogenry-for-the-treatment-of-retinitis-pigmentosa-with-severe-vision-loss\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nanoscope Therapeutics Announces U.S. Food and Drug Administration Acceptance of Biologics License Application for MOGENRY for the Treatment of Retinitis Pigmentosa with Severe Vision Loss - 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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