{"id":9863,"date":"2025-11-04T06:18:57","date_gmt":"2025-11-04T12:18:57","guid":{"rendered":"https:\/\/nanostherapeutics.com\/?p=9863"},"modified":"2025-11-04T10:07:10","modified_gmt":"2025-11-04T16:07:10","slug":"nanoscope-therapeutics-reports-five-year-safety-results-from-phase-1-2a-follow-up-study-of-mco-010-optogenetic-therapy-in-retinitis-pigmentosa","status":"publish","type":"post","link":"https:\/\/nanostherapeutics.com\/es\/2025\/11\/04\/nanoscope-therapeutics-reports-five-year-safety-results-from-phase-1-2a-follow-up-study-of-mco-010-optogenetic-therapy-in-retinitis-pigmentosa\/","title":{"rendered":"Nanoscope Therapeutics informa sobre los resultados de seguridad a cinco a\u00f1os del estudio de seguimiento de fase 1\/2a de la terapia optogen\u00e9tica MCO-010 en retinosis pigmentaria."},"content":{"rendered":"
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DALLAS<\/span>,\u00a04 de noviembre de 2025<\/span>\u00a0 \u2014 Nanoscopio Therapeutics Inc.<\/a>\u00a0anunci\u00f3 hoy resultados positivos de seguridad a largo plazo de su\u00a0EXTENDER<\/b>\u00a0Estudio, un seguimiento de cinco a\u00f1os de los participantes que recibieron una \u00fanica inyecci\u00f3n intrav\u00edtrea de MCO-010 en un ensayo anterior de fase 1\/2a.\u00a0<\/p>

El estudio EXTEND realiz\u00f3 un seguimiento a diez participantes con retinosis pigmentaria (RP) avanzada que hab\u00edan recibido previamente MCO-010, una terapia optogen\u00e9tica dise\u00f1ada para restaurar la visi\u00f3n utilizando la plataforma patentada Multi-Characteristic Opsin (MCO) de Nanoscope.<\/p>

EXTEND confirm\u00f3 que\u00a0Una \u00fanica inyecci\u00f3n intrav\u00edtrea de MCO-010 es segura y bien tolerada durante cinco a\u00f1os.<\/b>, sin efectos adversos graves ni nuevas se\u00f1ales de seguridad, junto con\u00a0mejoras en la calidad de vida observadas durante los mismos cinco a\u00f1os<\/b>.<\/p>

S\u00f3lido perfil de seguridad a largo plazo<\/b><\/p>

Durante cinco a\u00f1os, el perfil de seguridad se mantuvo constante entre el ensayo de fase 1\/2a y el per\u00edodo de seguimiento a largo plazo, con inflamaci\u00f3n transitoria controlable, sin interrupciones del tratamiento y sin nuevas se\u00f1ales de seguridad.<\/p>

\u201cEstos resultados demuestran la excelente seguridad y tolerabilidad a largo plazo de MCO-010, incluso cinco a\u00f1os despu\u00e9s de una sola inyecci\u00f3n\u201d, dijo\u00a0Samarendra Mohanty, PhD, Presidente y Director Cient\u00edfico de Nanoscope.<\/a>. \u201cLa ausencia de se\u00f1ales de seguridad graves y la alta tasa de retenci\u00f3n de participantes subrayan el potencial de MCO-010 como una terapia duradera y no invasiva para pacientes con retinosis pigmentaria y p\u00e9rdida de visi\u00f3n severa.\u201d<\/p>

Eficacia duradera<\/b><\/p>

Durante el ensayo inicial, los participantes que recibieron una dosis m\u00e1s alta de MCO-010 demostraron mejoras estad\u00edsticamente significativas en la agudeza visual despu\u00e9s de un a\u00f1o. Los participantes continuaron informando\u00a0calidad de vida relacionada con la visi\u00f3n estable o mejorada<\/b>\u00a0Durante el per\u00edodo de cinco a\u00f1os, en particular en actividades a distancia y medidas de independencia espec\u00edficas para la visi\u00f3n.\u00a0<\/p>

Los datos fueron presentados recientemente en el\u00a034th<\/sup>\u00a0Conferencia Anual de la Sociedad Vitreorretiniana \u2013 India<\/a>.<\/p>

Acerca de Nanoscope Therapeutics
<\/b>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. Nanoscope ha iniciado una presentaci\u00f3n continua de la solicitud de licencia biol\u00f3gica (BLA) ante la FDA para su principal producto, MCO-010, en el tratamiento de pacientes con p\u00e9rdida grave de visi\u00f3n por retinosis pigmentaria. De ser aprobado, MCO-010 tiene el potencial de convertirse en el tratamiento est\u00e1ndar para pacientes con retinosis pigmentaria. La compa\u00f1\u00eda tambi\u00e9n ha mostrado resultados prometedores con MCO-010 para el tratamiento de la enfermedad de Stargardt (ES). MCO-010 ha recibido las designaciones de v\u00eda r\u00e1pida y medicamento hu\u00e9rfano de la FDA para la retinosis pigmentaria y la ES, junto con la designaci\u00f3n RMAT para la ES, y las designaciones de medicamento hu\u00e9rfano de la EMA para cubrir distrofias dominantes de bastones y conos, tanto sindr\u00f3micas como no sindr\u00f3micas, y distrofias maculares. Se espera que un programa de fase 2 para MCO en atrofia geogr\u00e1fica (AG) comience a finales de 2025.<\/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":"

DALLAS,\u00a0Nov. 4, 2025\u00a0 \u2014 Nanoscope Therapeutics Inc.\u00a0announced today positive long-term safety results from its\u00a0EXTEND\u00a0study, a five-year follow-up of participants who received a single intravitreal injection of MCO-010 in an earlier Phase 1\/2a trial.\u00a0 The EXTEND study followed ten participants with advanced retinitis pigmentosa (RP) who had previously received MCO-010, an optogenetic therapy designed to restore […]<\/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-9863","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-home-page","category-nanoscope-press-release"],"yoast_head":"\nNanoscope Therapeutics Reports Five-Year Safety Results from Phase 1\/2a Follow-Up Study of MCO-010 Optogenetic Therapy in 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. 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