{"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-Oct. 31, 2024 &#8212; 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 presented by\u00a0Allen C. Ho, MD, FACS, FASRS, Director of Retina Research and Co-Director of the Retina Service at Wills Eye Hospital, and Chief Medical Advisor of Nanoscope, on\u00a0October 20, 2024 at the recently concluded\u00a0AAO 2024 Annual Meeting.\n\nDuring his presentation titled &#8220;Efficacy and Safety of MCO-010 Optogenetic Therapy for Vision Restoration in Patients With Severe Vision Loss Due to RP: Two-Year TOPLINE Results From a Phase\u00a0<span class=\"xn-money\">2b<\/span>\/3 Ensayo cl\u00ednico aleatorizado y controlado con placebo (RESTORE)\u201d, el Dr. Ho destac\u00f3 el beneficio medido de una mejora de la agudeza visual mejor corregida (MAVC) media de ~0,3 LogMAR (equivalente a 3 l\u00edneas, 15 letras) que se mantuvo en puntos temporales 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&#8220;The durable statistically significant vision improvement achieved at multiple time points during the 2-year study is highly noteworthy. This degree of improvement has never been observed in a randomized, controlled trial of a highly heterogeneous severe vision-loss patient population,&#8221; said Dr. Ho. &#8220;These findings deliver hope to patients and ophthalmologists that a solution is close to being found. We are finally on the brink of an impactful in-office, mutation-agnostic gene therapy for people with severe vision loss.&#8221;\n\nRESTORE is the first-ever RCT to show statistically significant visual acuity improvement in the RP patient population and a key part of the upcoming BLA submission planned for Nanoscope&#8217;s RP program. The RESTORE study design has been\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>.\n\n&#8220;Nanoscope is proud to be a leader in the optogenetic space, advancing a mutation and disease agnostic therapy designed for optimal performance with rapid kinetics and sensitivity across the visible light spectrum and at ambient light levels,&#8221; said\u00a0Sulagna Bhattacharya, co-founder, and Chief Executive Officer of Nanoscope. &#8220;We recognize the high unmet need, and we are working diligently to bring MCO-010 to these patients with permanent and progressive vision loss from retinal degeneration. They are our North Star.&#8221;\n\n<b>Acerca de Nanoscope Therapeutics Inc.<br class=\"dnr\" \/><\/b>Nanoscope Therapeutics est\u00e1 desarrollando terapias optogen\u00e9ticas que restauran la visi\u00f3n y que no dependen de los genes para los millones de pacientes que han perdido la visi\u00f3n a causa de enfermedades degenerativas de la retina, para las que no existe cura. El principal activo de la empresa, MCO-010, inform\u00f3 recientemente los resultados principales del ensayo cl\u00ednico RESTORE de fase 2b, multic\u00e9ntrico, aleatorizado, de doble ciego y controlado con placebo en los EE. UU. para la retinitis pigmentosa (<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 &#8212; 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,"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 v28.3 - 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. 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