{"id":10077,"date":"2026-03-30T07:28:13","date_gmt":"2026-03-30T12:28:13","guid":{"rendered":"https:\/\/nanostherapeutics.com\/?p=10077"},"modified":"2026-03-30T07:31:03","modified_gmt":"2026-03-30T12:31:03","slug":"nanoscope-therapeutics-receives-orphan-drug-designation-in-saudi-arabia-for-mco-010-expands-global-regulatory-leadership-in-vision-restoration","status":"publish","type":"post","link":"https:\/\/nanostherapeutics.com\/es\/2026\/03\/30\/nanoscope-therapeutics-receives-orphan-drug-designation-in-saudi-arabia-for-mco-010-expands-global-regulatory-leadership-in-vision-restoration\/","title":{"rendered":"Nanoscope Therapeutics recibe la designaci\u00f3n de medicamento hu\u00e9rfano en Arabia Saudita para MCO-010 y ampl\u00eda su liderazgo regulatorio global en la restauraci\u00f3n de la visi\u00f3n."},"content":{"rendered":"
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DALLAS<\/span>,\u00a030 de marzo de 2026<\/span>\u00a0\u2014\u00a0Nanoscope Therapeutics, Inc.<\/a>, una empresa de biotecnolog\u00eda comprometida con 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 ha recibido la designaci\u00f3n de medicamento hu\u00e9rfano en el Reino de Arabia Saudita para su terapia principal, MCO-010, para la\u00a0Tratamiento de pacientes con distrofias retinianas hereditarias (DRH) que presentan p\u00e9rdida grave de visi\u00f3n.<\/b>.<\/p>

La amplia designaci\u00f3n otorgada por las autoridades reguladoras saud\u00edes refuerza a\u00fan m\u00e1s la creciente presencia regulatoria global de Nanoscope y refleja el creciente reconocimiento internacional de la plataforma patentada Multi-Characteristic Opsin (MCO) de la compa\u00f1\u00eda como una posible terapia optogen\u00e9tica pionera e independiente de la enfermedad para la restauraci\u00f3n de la visi\u00f3n.<\/p>

\u201cEl desarrollo de MCO-010 como terapia optogen\u00e9tica independiente de la enfermedad contin\u00faa progresando con las autoridades reguladoras de todo el mundo\u201d, dijo\u00a0Samarendra Mohanty, Ph.D., presidenta y directora cient\u00edfica de Nanoscope Therapeutics<\/b>. \u201cCon esta designaci\u00f3n en Arabia Saudita, estamos acelerando a\u00fan m\u00e1s nuestros esfuerzos para llevar esta terapia a pacientes de todo el mundo, incluso en regiones donde el acceso a tratamientos avanzados para la retina ha sido hist\u00f3ricamente limitado.\u201d<\/p>

Construyendo un marco regulatorio global en los principales mercados.<\/b><\/p>

La designaci\u00f3n saud\u00ed se basa en una serie de importantes hitos regulatorios en Estados Unidos, Jap\u00f3n y Europa, lo que sit\u00faa a MCO-010 entre las terapias optogen\u00e9ticas m\u00e1s avanzadas en desarrollo a nivel mundial.<\/p>

En Estados Unidos, MCO-010 ha recibido las designaciones de Medicamento Hu\u00e9rfano y V\u00eda R\u00e1pida para la retinosis pigmentaria, as\u00ed como las designaciones de Medicamento Hu\u00e9rfano, V\u00eda R\u00e1pida y Terapia Avanzada de Medicina Regenerativa (RMAT) para la enfermedad de Stargardt. Nanoscope tambi\u00e9n ha iniciado la presentaci\u00f3n continua de la Solicitud de Licencia para Productos Biol\u00f3gicos (BLA) para la retinosis pigmentaria, lo que subraya el progreso de la terapia en su fase final de desarrollo.<\/p>

En Jap\u00f3n, el Ministerio de Salud, Trabajo y Bienestar (MHLW) otorg\u00f3 a MCO-010 las designaciones de Sakigake (Producto M\u00e9dico Regenerativo Pionero) y Medicamento Hu\u00e9rfano para IRD, lo que marca la primera vez que una terapia g\u00e9nica para la retina recibe designaciones tan amplias para IRD en el pa\u00eds. Estas designaciones proporcionan una v\u00eda regulatoria acelerada, que incluye consultas prioritarias y la posibilidad de plazos de revisi\u00f3n m\u00e1s cortos.<\/p>

En toda Europa, MCO-010 ha recibido cinco designaciones de medicamento hu\u00e9rfano por parte de la Agencia Europea de Medicamentos (EMA), que abarcan una amplia gama de enfermedades relacionadas con la eritropoyesis, lo que respalda una estrategia regulatoria independiente de la enfermedad en m\u00faltiples indicaciones.<\/p>

Las distrofias retinianas hereditarias (DRH) son un grupo de enfermedades raras y progresivas que provocan una p\u00e9rdida grave de la visi\u00f3n o ceguera y que actualmente carecen de opciones de tratamiento.\u00a0Mediante el avance de los procesos regulatorios en Norteam\u00e9rica, Europa, Asia y ahora Oriente Medio, Nanoscope est\u00e1 impulsando una de las estrategias de desarrollo global m\u00e1s completas en terapia optogen\u00e9tica.<\/b><\/p>

Acerca de la plataforma MCO
<\/b>MCO es una plataforma terap\u00e9utica intrav\u00edtrea de una sola aplicaci\u00f3n, ambulatoria y aplicable a cualquier enfermedad, dise\u00f1ada para restaurar la visi\u00f3n en pacientes con degeneraci\u00f3n de fotorreceptores, incluyendo retinosis pigmentaria (RP), enfermedad de Stargardt (ES) y atrofia geogr\u00e1fica (AG). Al activar las c\u00e9lulas bipolares de la retina, altamente densas, para que sean sensibles a la luz, MCO aprovecha el circuito visual restante tras la muerte de los fotorreceptores. El tratamiento con MCO no requiere pruebas gen\u00e9ticas, cirug\u00eda invasiva ni dosis repetidas, lo que permite una amplia aplicabilidad en pacientes dentro de los flujos de trabajo habituales en las consultas de retina.<\/p>

Acerca de Nanoscope Therapeutics
<\/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 (RP) (NCT04945772<\/a>), se est\u00e1 llevando a cabo una presentaci\u00f3n continua de BLA a la FDA. Si se aprueba, MCO-010 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) (NCT05417126<\/a>) y planea iniciar una\u00a0Ensayo de registro de fase 3<\/a>\u00a0en 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 para cubrir 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 (Pionero) y Medicamento Hu\u00e9rfano en Jap\u00f3n por parte del MHLW y la designaci\u00f3n de Medicamento Hu\u00e9rfano en el Reino de Arabia Saudita. Tambi\u00e9n se espera que un programa de Fase 2 para MCO en atrofia geogr\u00e1fica (GA) comience en 2026. Otros programas listos para IND incluyen la amaurosis cong\u00e9nita de Leber (LCA).<\/p>

Contacto:
<\/b>Nanoscope Therapeutics, Inc
+1 (817) 857-1186
PR@nanostherapeutics.com<\/a>\u00a0<\/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,\u00a0March 30, 2026\u00a0\u2014\u00a0Nanoscope Therapeutics, Inc., a biotechnology company committed to developing and commercializing novel, disease-agnostic therapies for patients with photoreceptor loss and vision impairment due to retinal degeneration, today announced that it has received Orphan Drug Designation in the Kingdom of Saudi Arabia for its lead therapy, MCO-010, for the\u00a0treatment of patients with inherited retinal […]<\/p>\n","protected":false},"author":1,"featured_media":10078,"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-10077","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-home-page","category-nanoscope-press-release"],"yoast_head":"\nNanoscope Therapeutics Receives Orphan Drug Designation in Saudi Arabia for MCO-010, Expands Global Regulatory Leadership in Vision Restoration - 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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