{"id":5850,"date":"2024-10-31T16:10:24","date_gmt":"2024-10-31T21:10:24","guid":{"rendered":"https:\/\/nanostherapeutics.com\/?p=5850"},"modified":"2025-06-27T11:07:05","modified_gmt":"2025-06-27T16:07:05","slug":"nanoscope-presented-positive-2-year-randomized-controlled-trial-results-of-mco-010-for-retinitis-pigmentosa","status":"publish","type":"post","link":"https:\/\/nanostherapeutics.com\/es\/2024\/10\/31\/nanoscope-presented-positive-2-year-randomized-controlled-trial-results-of-mco-010-for-retinitis-pigmentosa\/","title":{"rendered":"Nanoscope present\u00f3 resultados positivos de un ensayo controlado y aleatorizado de dos a\u00f1os sobre MCO-010 para la retinitis pigmentosa"},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"5850\" class=\"elementor elementor-5850\" data-elementor-post-type=\"post\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-54ac0541 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"54ac0541\" 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-367865ba\" data-id=\"367865ba\" 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-45ffa5a0 elementor-widget elementor-widget-text-editor\" data-id=\"45ffa5a0\" 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\tDALLAS, 31 de octubre de 2024 \u2014 Nanoscope Therapeutics, Inc., una empresa de biotecnolog\u00eda en etapa de presentaci\u00f3n de solicitud de licencia biol\u00f3gica (BLA) que desarrolla terapias g\u00e9nicas para enfermedades degenerativas de la retina, anunci\u00f3 hoy que los resultados positivos de dos a\u00f1os del ensayo cl\u00ednico aleatorizado y controlado (ECA) de fase 2b RESTORE de su programa principal, MCO-010, una terapia g\u00e9nica independiente de la mutaci\u00f3n para pacientes con p\u00e9rdida de visi\u00f3n permanente y grave debido a retinosis pigmentaria (RP) avanzada, fueron presentados por Allen C. Ho, MD, FACS, FASRS, Director de Investigaci\u00f3n de Retina y Codirector del Servicio de Retina en Wills Eye Hospital, y Asesor M\u00e9dico Jefe de Nanoscope, el 20 de octubre de 2024 en la Reuni\u00f3n Anual AAO 2024 recientemente concluida. Durante su presentaci\u00f3n titulada &quot;Eficacia y seguridad de la terapia optogen\u00e9tica MCO-010 para la restauraci\u00f3n de la visi\u00f3n en pacientes con p\u00e9rdida de visi\u00f3n grave debido a RP: resultados preliminares de dos a\u00f1os de un ensayo de fase 2b\u00a0<span class=\"xn-money\">2b<\/span>En el ensayo cl\u00ednico aleatorizado controlado con placebo (RESTORE), el Dr. Ho destac\u00f3 el beneficio medido de una mejora media de la mejor agudeza visual corregida (BCVA) de aproximadamente 0,3 LogMAR (equivalente a 3 l\u00edneas y 15 letras) que se mantuvo en momentos posteriores durante el transcurso del ensayo controlado con placebo. Otros hallazgos incluyeron:\n<ul type=\"disc\">\n \t<li>El grupo de dosis alta de MCO-010 tuvo mejoras medias de 0,337 \u00b1 0,0829 y 0,539 \u00b1 0,1032 LogMAR (frente al grupo de control simulado, p = 0,0209 y 0,0014) en las semanas 52 (primaria) y 76 (secundaria clave), respectivamente, y el grupo de dosis baja de MCO-010 tuvo mejoras medias de 0,382 \u00b1 0,1244 y 0,374 \u00b1 0,1332 LogMAR (frente al grupo de control simulado, p = 0,0290 y 0,0652) en los mismos puntos temporales (<a href=\"https:\/\/nanostherapeutics.com\/es\/2024\/03\/26\/nanoscope-therapeutics-announces-top-line-results-from-ph2-trial-of-mco-010-for-retinitis-pigmentosa\/\" target=\"_blank\" rel=\"nofollow noopener\">Previamente anunciado<\/a>).<\/li>\n \t<li>En la semana 52, 7 de 18 (39%) individuos tratados con MCO-010 tuvieron una mejora de la agudeza visual corregida \u22650,3 LogMAR; 10 de 18 (56%) alcanzaron este umbral en la semana 76.<\/li>\n \t<li>El an\u00e1lisis longitudinal muestra una mejora media de la agudeza visual corregida (AVMC) con significaci\u00f3n estad\u00edstica en comparaci\u00f3n con el control simulado en las visitas de las semanas 36 a 88.<\/li>\n \t<li>Los perfiles del \u00e1rea bajo la curva de agudeza visual corregida (MAVC) hasta las semanas 52, 76 y 100 fueron 5 veces mayores y estad\u00edsticamente significativos para ambos grupos de dosis de MCO-010 en comparaci\u00f3n con el control simulado.<\/li>\n \t<li>El MCO-010 fue bien tolerado y no se informaron eventos adversos graves en los grupos que recibieron MCO-010. Los eventos adversos notificados con mayor frecuencia fueron la aparici\u00f3n de c\u00e9lulas en la c\u00e1mara anterior (44% MCO-010, 22% placebo-control) y la hipertensi\u00f3n ocular (39% MCO-010, 11% placebo-control). Estos eventos adversos se resolvieron o se controlaron con medicaci\u00f3n t\u00f3pica.<\/li>\n<\/ul>\n\u201cLa mejora visual duradera y estad\u00edsticamente significativa lograda en m\u00faltiples momentos durante el estudio de 2 a\u00f1os es sumamente destacable. Este grado de mejora nunca se hab\u00eda observado en un ensayo controlado aleatorizado de una poblaci\u00f3n de pacientes con p\u00e9rdida visual grave altamente heterog\u00e9nea\u201d, dijo el Dr. Ho. \u201cEstos hallazgos brindan esperanza a pacientes y oftalm\u00f3logos de que una soluci\u00f3n est\u00e1 cerca de ser encontrada. Finalmente estamos al borde de una terapia g\u00e9nica impactante, ambulatoria e independiente de la mutaci\u00f3n para personas con p\u00e9rdida visual grave\u201d. RESTORE es el primer ECA que muestra una mejora estad\u00edsticamente significativa de la agudeza visual en la poblaci\u00f3n de pacientes con retinosis pigmentaria y una parte clave de la pr\u00f3xima solicitud de licencia biol\u00f3gica (BLA) prevista para el programa de retinosis pigmentaria de Nanoscope. El dise\u00f1o del estudio RESTORE ha sido\u00a0<a href=\"https:\/\/nanostherapeutics.com\/es\/2024\/03\/26\/nanoscope-therapeutics-announces-top-line-results-from-ph2-trial-of-mco-010-for-retinitis-pigmentosa\/\" target=\"_blank\" rel=\"nofollow noopener\">Previamente anunciado<\/a>.\u201cEn Nanoscope nos enorgullece ser l\u00edderes en el campo de la optogen\u00e9tica, impulsando una terapia independiente de mutaciones y enfermedades, dise\u00f1ada para un rendimiento \u00f3ptimo con cin\u00e9tica r\u00e1pida y sensibilidad en todo el espectro de luz visible y a niveles de luz ambiental\u201d, declar\u00f3 Sulagna Bhattacharya, cofundadora y directora ejecutiva de Nanoscope. \u201cReconocemos la gran necesidad insatisfecha y trabajamos con diligencia para que MCO-010 llegue a estos pacientes con p\u00e9rdida de visi\u00f3n permanente y progresiva debido a la degeneraci\u00f3n retiniana. Son nuestra principal prioridad\u201d.\u201d\n\n<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\/NCT05417126\" target=\"_blank\" rel=\"nofollow noopener\">NCT04945772<\/a>). La empresa ha completado el ensayo de fase 2 STARLIGHT de la terapia MCO-010 en pacientes con Stargardt (<a href=\"https:\/\/clinicaltrials.gov\/study\/NCT04945772\" target=\"_blank\" rel=\"nofollow noopener\">NCT05417126<\/a>) y recientemente\u00a0<a href=\"https:\/\/www.prnewswire.com\/news-releases\/nanoscope-therapeutics-announces-end-of-phase-2-meeting-with-us-fda-and-plan-to-initiate-a-phase-3-clinical-trial-of-mco-010-to-treat-stargardt-macular-degeneration-302247017.html\" target=\"_blank\" rel=\"nofollow noopener\">anunci\u00f3 planes para iniciar una Fase 3<\/a>\u00a0Ensayo de registro en el primer trimestre de 2025. MCO-010 ha recibido designaciones de v\u00eda r\u00e1pida de la FDA y designaciones 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.\n\n<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>\n\n<\/div>\n<\/div>\n<\/section><\/article>\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>DALLAS-Oct. 31, 2024 \u2014 Nanoscope Therapeutics, Inc., a BLA filing-stage biotechnology company developing gene therapies for retinal degenerative diseases, today announced that positive 2-year results from the Phase\u00a02b\u00a0RESTORE randomized, controlled clinical trial (RCT) of its lead program, MCO-010,\u00a0a mutation-agnostic gene therapy for patients with permanent and severe vision loss from advanced retinitis pigmentosa (RP) were [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":5852,"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-5850","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 Presented Positive 2-Year Randomized, Controlled Trial Results of MCO-010 for 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\/31\/nanoscope-presented-positive-2-year-randomized-controlled-trial-results-of-mco-010-for-retinitis-pigmentosa\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nanoscope Presented Positive 2-Year Randomized, Controlled Trial Results of MCO-010 for 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. 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 property=\"og:url\" content=\"https:\/\/nanostherapeutics.com\/es\/2024\/10\/31\/nanoscope-presented-positive-2-year-randomized-controlled-trial-results-of-mco-010-for-retinitis-pigmentosa\/\" \/>\n<meta property=\"og:site_name\" content=\"Nanoscope Therapeutics\" \/>\n<meta property=\"article:published_time\" content=\"2024-10-31T21:10:24+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-06-27T16:07:05+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/nanostherapeutics.com\/wp-content\/uploads\/2024\/10\/NSCOPE_LI_AAO_Post_results.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"1200\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Nanoscope Therapeutics\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:image\" content=\"https:\/\/nanostherapeutics.com\/wp-content\/uploads\/2024\/10\/NSCOPE_LI_AAO_Post_results.jpg\" \/>\n<meta name=\"twitter:creator\" content=\"@NSTherapeutics\" \/>\n<meta name=\"twitter:site\" content=\"@NSTherapeutics\" \/>\n<meta name=\"twitter:label1\" content=\"Escrito por\" \/>\n\t<meta name=\"twitter:data1\" content=\"Nanoscope Therapeutics\" \/>\n\t<meta name=\"twitter:label2\" content=\"Tiempo de lectura\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/2024\\\/10\\\/31\\\/nanoscope-presented-positive-2-year-randomized-controlled-trial-results-of-mco-010-for-retinitis-pigmentosa\\\/#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/2024\\\/10\\\/31\\\/nanoscope-presented-positive-2-year-randomized-controlled-trial-results-of-mco-010-for-retinitis-pigmentosa\\\/\"},\"author\":{\"name\":\"Nanoscope Therapeutics\",\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/#\\\/schema\\\/person\\\/5aeedc9aef0946fe8f96f98f7b1808a2\"},\"headline\":\"Nanoscope Presented Positive 2-Year Randomized, Controlled Trial Results of MCO-010 for Retinitis Pigmentosa\",\"datePublished\":\"2024-10-31T21:10:24+00:00\",\"dateModified\":\"2025-06-27T16:07:05+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/2024\\\/10\\\/31\\\/nanoscope-presented-positive-2-year-randomized-controlled-trial-results-of-mco-010-for-retinitis-pigmentosa\\\/\"},\"wordCount\":627,\"publisher\":{\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/#organization\"},\"image\":{\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/2024\\\/10\\\/31\\\/nanoscope-presented-positive-2-year-randomized-controlled-trial-results-of-mco-010-for-retinitis-pigmentosa\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/nanostherapeutics.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/NSCOPE_LI_AAO_Post_results.jpg\",\"articleSection\":[\"Home Page\",\"Nanoscope Press Release\"],\"inLanguage\":\"es\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/2024\\\/10\\\/31\\\/nanoscope-presented-positive-2-year-randomized-controlled-trial-results-of-mco-010-for-retinitis-pigmentosa\\\/\",\"url\":\"https:\\\/\\\/nanostherapeutics.com\\\/2024\\\/10\\\/31\\\/nanoscope-presented-positive-2-year-randomized-controlled-trial-results-of-mco-010-for-retinitis-pigmentosa\\\/\",\"name\":\"Nanoscope Presented Positive 2-Year Randomized, Controlled Trial Results of MCO-010 for Retinitis Pigmentosa - Nanoscope Therapeutics\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/2024\\\/10\\\/31\\\/nanoscope-presented-positive-2-year-randomized-controlled-trial-results-of-mco-010-for-retinitis-pigmentosa\\\/#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/nanostherapeutics.com\\\/2024\\\/10\\\/31\\\/nanoscope-presented-positive-2-year-randomized-controlled-trial-results-of-mco-010-for-retinitis-pigmentosa\\\/#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/nanostherapeutics.com\\\/wp-content\\\/uploads\\\/2024\\\/10\\\/NSCOPE_LI_AAO_Post_results.jpg\",\"datePublished\":\"2024-10-31T21:10:24+00:00\",\"dateModified\":\"2025-06-27T16:07:05+00:00\",\"description\":\"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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