{"id":9392,"date":"2025-08-14T09:42:09","date_gmt":"2025-08-14T14:42:09","guid":{"rendered":"https:\/\/nanostherapeutics.com\/?p=9392"},"modified":"2025-08-14T09:45:07","modified_gmt":"2025-08-14T14:45:07","slug":"nanoscope-therapeutics-announces-publication-of-starlight-phase-2-study-evaluating-mco-010-gene-agnostic-therapy-in-patients-with-stargardt-disease","status":"publish","type":"post","link":"https:\/\/nanostherapeutics.com\/es\/2025\/08\/14\/nanoscope-therapeutics-announces-publication-of-starlight-phase-2-study-evaluating-mco-010-gene-agnostic-therapy-in-patients-with-stargardt-disease\/","title":{"rendered":"Nanoscope Therapeutics anuncia la publicaci\u00f3n del estudio de fase 2 STARLIGHT que eval\u00faa la terapia gen\u00e9tica MCO-010 en pacientes con enfermedad de Stargardt."},"content":{"rendered":"<div data-elementor-type=\"wp-post\" data-elementor-id=\"9392\" class=\"elementor elementor-9392\" 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<h3 style=\"text-align: center;\"><i>El<\/i><i>\u00a0El estudio STARLIGHT es el primer y \u00fanico ensayo cl\u00ednico que demuestra una mejor\u00eda en la visi\u00f3n de pacientes con la enfermedad de Stargardt.<\/i><\/h3><h3 style=\"text-align: center;\"><i>MCO-010\u00a0<\/i><i>demostr\u00f3 una mejora media de la agudeza visual de 12 letras ETDRS durante 48 semanas en\u00a0<\/i><i>pacientes con atrofia confinada a la m\u00e1cula, sin informes de eventos adversos graves.<\/i><\/h3><h3 style=\"text-align: center;\"><i>Nanoscopio\u00a0<\/i><i>ha completado una reuni\u00f3n de fin de fase 2 con la FDA y\u00a0<\/i><i>Planea iniciar un ensayo de fase 3 que permita el registro en pacientes con enfermedad de Stargardt para finales de 2025.<\/i><i>.<\/i><\/h3><p><span class=\"legendSpanClass\"><span class=\"xn-location\">DALLAS<\/span><\/span>,\u00a0<span class=\"legendSpanClass\"><span class=\"xn-chron\">14 de agosto de 2025<\/span><\/span> \u2014\u00a0<b><a href=\"http:\/\/nanostherapeutics.com\/es\/\" target=\"_blank\" rel=\"nofollow noopener\">Nanoscope Therapeutics Inc.,<\/a><\/b>\u00a0una empresa de biotecnolog\u00eda comprometida con el desarrollo y la comercializaci\u00f3n de nuevas terapias gen\u00e9ticas independientes para pacientes que sufren p\u00e9rdida de visi\u00f3n debido a enfermedades degenerativas de la retina, anunci\u00f3 hoy la publicaci\u00f3n de resultados positivos de su ensayo cl\u00ednico STARLIGHT en\u00a0<i><a href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S2589537025003621\" target=\"_blank\" rel=\"nofollow noopener\">Medicina Cl\u00ednica Electr\u00f3nica, parte de The Lancet Discovery Science<\/a><\/i><i>.<\/i>\u00a0STARLIGHT es el primer y \u00fanico ensayo cl\u00ednico que demuestra mejoras en la visi\u00f3n de pacientes con enfermedad de Stargardt (ES).<\/p><p>STARLIGHT es un estudio de fase 2, abierto, dise\u00f1ado para evaluar la seguridad y la eficacia de una \u00fanica inyecci\u00f3n intrav\u00edtrea de la terapia MCO-010, independiente del gen, en seis participantes con p\u00e9rdida grave de la visi\u00f3n debido a la degeneraci\u00f3n macular asociada a la edad (DSE).<\/p><p>Entre los principales hallazgos se incluyen:<\/p><ul type=\"disc\"><li>La mejora media en la mejor agudeza visual corregida (BCVA) desde el inicio hasta la semana 48 fue:<ul type=\"disc\"><li>Para todos los pacientes, +5,5 y +9,0 letras ETDRS sin y con una ayuda visual port\u00e1til para baja visi\u00f3n, respectivamente.<\/li><li>En individuos con atrofia confinada a la m\u00e1cula, +12,0 y +32,0 letras ETDRS, sin y con una ayuda visual port\u00e1til para baja visi\u00f3n, respectivamente.<\/li><\/ul><\/li><li>Algunos pacientes observaron una mejor\u00eda en la visi\u00f3n tan solo 4 semanas despu\u00e9s del tratamiento, la cual se mantuvo durante toda la duraci\u00f3n del estudio.<\/li><li>MCO-010 fue bien tolerado y no se notificaron efectos adversos graves durante 48 semanas.<\/li><\/ul><p>La enfermedad de Stargardt, tambi\u00e9n conocida como distrofia macular juvenil, es una de las principales causas de p\u00e9rdida de visi\u00f3n en ni\u00f1os. Afecta a m\u00e1s de 40\u00a0000 personas en Estados Unidos y deja a m\u00e1s de 20\u00a0000 legalmente ciegas. En los pacientes con enfermedad de Stargardt, los fotorreceptores de la m\u00e1cula, sensibles a la luz, se deterioran, lo que provoca la p\u00e9rdida de la visi\u00f3n central. Actualmente, no existen tratamientos aprobados para esta enfermedad.<\/p><p>\u201cSi bien se trat\u00f3 de un estudio abierto, este es uno de los primeros estudios que demuestra una mejor\u00eda en la visi\u00f3n en pacientes con la enfermedad de Stargardt. Este es un hallazgo notable, ya que estos pacientes suelen experimentar una p\u00e9rdida irreversible de la visi\u00f3n central a lo largo de su vida\u201d, agreg\u00f3.\u00a0<a href=\"https:\/\/c212.net\/c\/link\/?t=0&l=en&o=4488615-1&h=1608611289&u=https%3A%2F%2Furl.avanan.click%2Fv2%2Fr01%2F___https%3A%2Furldefense.proofpoint.com%2FA7dzwq%3Fz%3Dmyyux-8F__rji.rnfrn.jiz_kfhzqyD_gDwts-7Iq-7Iqfr-7Iri%26i%3DIBRLfV%26h%3DjzL4xyhfYIqqAnrJSbgao2wBvTk-A%2FF_Hiuls0knnRR%26w%3DwlVPiylV5SfKWXYNqoZGHixACbVoRTARH8hXKnE6KSJ%26r%3Df004s34KPNHpKl1uQqhZnTz7q_8%2F8_Oxl5VGhQQ_IET15iRkYfunt1xUsZtQ6rLW%26x%3DJNN%2FZjtpIyfy7jr3k_pc6S7H44t1PhA1c1I2C%2FRS*%7E*Wl%26j%3D___.YXAzOm5hbm9zY29wZXRoZXJhcGV1dGljczphOm86NjM2NmU3MGYwOGZjMDcxNWVhNTY4YzM0NmQ4NTcyNDE6NzpkMWY1OjZmMTc1MDhiNDc3NmMwZmE2N2RhNmRhZTBjYzBlMjc0YzkzZjk2ODFiYzdiNjYxZDMyMWNlMWUxNzVjYzk0ZDQ6aDpUOlQ&a=Byron+Lam%2C+MD%2C+Professor+of+Ophthalmology+at+Bascom+Palmer+Eye+Institute\" target=\"_blank\" rel=\"nofollow noopener\"><span class=\"xn-person\">Byron Lam<\/span>, Doctor en Medicina, Profesor de Oftalmolog\u00eda en el Instituto Oftalmol\u00f3gico Bascom Palmer<\/a>, autor principal e investigador principal del estudio STARLIGHT. \u201cEstoy encantado de formar parte del pr\u00f3ximo ensayo de fase 3 de MCO-010 en la enfermedad de Stargardt, contribuyendo al avance de esta prometedora terapia hacia su posible aprobaci\u00f3n\u201d.\u201d<\/p><p>\u201cAgradecemos a los pacientes y a los investigadores que participaron en el ensayo\u201d, a\u00f1adi\u00f3.\u00a0<a href=\"https:\/\/c212.net\/c\/link\/?t=0&l=en&o=4488615-1&h=274283711&u=https%3A%2F%2Furl.avanan.click%2Fv2%2F___https%3A%2Fnanostherapeutics.com%2Fwho-we-are%2Fsamarendra-mohanty%2F___.YXAzOm5hbm9zY29wZXRoZXJhcGV1dGljczphOm86NWVlNTM3ZjAzZTU0YzUwZGZmOGUzMWQ4OGFlNjcwYzU6NjphOTFjOjM1MWFlNzhjMGM1ZGM2ZDFkMzAzZGU2YmM5ZDJlNmI0YTY2NWUwOTA4NDgzZjQ0NzZmODVmN2RkZDlhYjk2Nzg6cDpUOk4&a=Samarendra+Mohanty%2C+PhD%2C+President+%2F+Chief+Scientific+Officer\" target=\"_blank\" rel=\"nofollow noopener\"><span class=\"xn-person\">Samarendra Mohanty<\/span>, Doctor en Filosof\u00eda, Presidente\/Director Cient\u00edfico<\/a>. \u201cLos resultados que hemos observado en el estudio STARLIGHT para pacientes con enfermedad de Stargardt refuerzan el potencial terap\u00e9utico de nuestra plataforma MCO-010, independiente del gen, bas\u00e1ndose en los resultados positivos obtenidos tanto en poblaciones con enfermedad de Stargardt como con retinosis pigmentaria.\u201d<\/p><p>El manuscrito publicado, titulado\u00a0<a href=\"https:\/\/www.sciencedirect.com\/science\/article\/pii\/S2589537025003621\" target=\"_blank\" rel=\"nofollow noopener\">\u201c<i>Seguridad y eficacia de la terapia optogen\u00e9tica MCO-010 en pacientes con enfermedad de Stargardt en EE. UU. (STARLIGHT): un ensayo cl\u00ednico multic\u00e9ntrico de fase 2, abierto.\u201d<\/i><\/a>, ya est\u00e1 disponible en l\u00ednea y aparecer\u00e1 en una pr\u00f3xima edici\u00f3n impresa de\u00a0<i>La Lanceta.<\/i><\/p><p><b>Acerca de MCO-010<\/b><b>\u00a0y el\u00a0<\/b><b>Pr\u00f3ximamente\u00a0<\/b><b>Estudio STARGAZE Fase 3<\/b><\/p><p>El MCO-010 patentado de Nanoscope (<i>sonpiretigene isteparvovec<\/i>MCO-010 es una terapia intrav\u00edtrea de administraci\u00f3n \u00fanica, realizada en consulta, que no depende del gen MCO-010 y est\u00e1 dise\u00f1ada para restaurar la visi\u00f3n en pacientes con degeneraci\u00f3n retiniana avanzada. 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. La terapia con MCO-010 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><p>STARGAZE es un estudio de fase 3, aleatorizado, doble ciego y controlado con placebo, dise\u00f1ado para evaluar la eficacia y seguridad de MCO-010 en pacientes con enfermedad de Stargardt. Tras una exitosa reuni\u00f3n de fin de fase 2 y en consonancia con las directrices de la FDA, este estudio, que permitir\u00e1 su registro, incluir\u00e1 aproximadamente 60 pacientes en varios centros. El criterio de valoraci\u00f3n principal es el cambio en la agudeza visual corregida (BCVA) utilizando una tabla de visi\u00f3n est\u00e1ndar frente a un grupo de control con placebo. Un criterio de valoraci\u00f3n secundario clave evaluar\u00e1 la mejora en el reconocimiento de formas con diferentes niveles de luminancia. Se esperan los resultados preliminares en 2027.<\/p><p>Para obtener m\u00e1s informaci\u00f3n sobre MCO-010 y Nanoscope Therapeutics, visite:\u00a0<a href=\"https:\/\/c212.net\/c\/link\/?t=0&l=en&o=4488615-1&h=4272928033&u=https%3A%2F%2Fwww.nanostherapeutics.com%2F&a=www.nanostherapeutics.com\" target=\"_blank\" rel=\"nofollow noopener\">www.nanostherapeutics.com<\/a>.<\/p><p><b>Acerca de Nanoscope Therapeutics<\/b><\/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 de la fase RESTORE\u00a0<span class=\"xn-money\">2b<\/span>\u00a0Ensayo cl\u00ednico multic\u00e9ntrico, aleatorizado, doble ciego y controlado con placebo para la retinosis pigmentaria (RP) (<a href=\"https:\/\/c212.net\/c\/link\/?t=0&l=en&o=4488615-1&h=648193028&u=https%3A%2F%2Furl.avanan.click%2Fv2%2F___https%3A%2Fclinicaltrials.gov%2Fstudy%2FNCT04945772___.YXAzOm5hbm9zY29wZXRoZXJhcGV1dGljczphOm86ODBiMzBmNTQ3ZmEyNzYzOWY5NDk5ODg3OWY5NDBlOTQ6Njo0YWVjOmU5YTIyOGNiZDRhMzQ3NzJkNWE0NDg0MjliN2JlZjMxN2Q1ZmM4NWU2MTBiOWQwNjZkM2ZjZDZkMGQ5NjVjMWI6cDpUOk4&a=NCT04945772\" target=\"_blank\" rel=\"nofollow noopener\">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:\/\/c212.net\/c\/link\/?t=0&l=en&o=4488615-1&h=1428603299&u=https%3A%2F%2Furl.avanan.click%2Fv2%2F___https%3A%2Fclinicaltrials.gov%2Fstudy%2FNCT05417126___.YXAzOm5hbm9zY29wZXRoZXJhcGV1dGljczphOm86ODBiMzBmNTQ3ZmEyNzYzOWY5NDk5ODg3OWY5NDBlOTQ6NjpjMWRkOmVmOTBkMjllMDdkZTAwZGRhNmY0NGIxZWVmYzExOWI2OWU5ZGY3YTRjYTQ5ZTMyZjZlOTQxYTJjOGZkMjM4YmM6cDpUOk4&a=NCT05417126\" target=\"_blank\" rel=\"nofollow noopener\">NCT05417126<\/a>) y planea iniciar una\u00a0<a href=\"https:\/\/c212.net\/c\/link\/?t=0&l=en&o=4488615-1&h=3026779660&u=https%3A%2F%2Furl.avanan.click%2Fv2%2F___https%3A%2Fnanostherapeutics.com%2F2024%2F09%2F12%2Fnanoscope-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%2F___.YXAzOm5hbm9zY29wZXRoZXJhcGV1dGljczphOm86ODBiMzBmNTQ3ZmEyNzYzOWY5NDk5ODg3OWY5NDBlOTQ6NjoxM2E1OjdmZGE1NmRiYjg5MmIyYzAzOGRlYzc4YWY3ZmRlZmNmMjhlZjNkZmQ2Y2Y0MTE1ZWQ2MzMwMDg1MTAwMDAwYzk6cDpUOk4&a=Phase+3+registrational+trial\" target=\"_blank\" rel=\"nofollow noopener\">Ensayo 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. 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><b>Contacto:<br class=\"dnr\" \/><\/b>Terap\u00e9utica del nanoscopio<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><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":"<p>The\u00a0STARLIGHT study is the first and only clinical trial to demonstrate vision improvement in patients with Stargardt disease. MCO-010\u00a0demonstrated mean visual acuity improvement of 12 ETDRS letters over 48 weeks in\u00a0patients with atrophy confined to the macula -with no reports of serious adverse events. Nanoscope\u00a0has completed an end of phase 2 meeting with the FDA [&hellip;]<\/p>\n","protected":false},"author":1,"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-9392","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 Announces Publication of STARLIGHT Phase 2 Study Evaluating MCO-010 Gene-Agnostic Therapy in Patients with Stargardt Disease - 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\/08\/14\/nanoscope-therapeutics-announces-publication-of-starlight-phase-2-study-evaluating-mco-010-gene-agnostic-therapy-in-patients-with-stargardt-disease\/\" \/>\n<meta property=\"og:locale\" content=\"es_MX\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nanoscope Therapeutics Announces Publication of STARLIGHT Phase 2 Study Evaluating MCO-010 Gene-Agnostic Therapy in Patients with Stargardt Disease - 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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