{"id":8951,"date":"2025-06-26T12:35:22","date_gmt":"2025-06-26T17:35:22","guid":{"rendered":"https:\/\/nanostherapeutics.com\/?page_id=8951"},"modified":"2025-08-26T19:36:23","modified_gmt":"2025-08-27T00:36:23","slug":"compassionate-use-policy","status":"publish","type":"page","link":"https:\/\/nanostherapeutics.com\/es\/compassionate-use-policy\/","title":{"rendered":"Pol\u00edtica de uso compasivo"},"content":{"rendered":"<div data-elementor-type=\"wp-page\" data-elementor-id=\"8951\" class=\"elementor elementor-8951\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-c9cd9ec elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"c9cd9ec\" 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-705608a\" data-id=\"705608a\" 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-5da0260 elementor-widget elementor-widget-heading\" data-id=\"5da0260\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Nanoscope Therapeutics, Inc.<\/br>\nPol\u00edtica de acceso ampliado<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-bab875b elementor-widget elementor-widget-spacer\" data-id=\"bab875b\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-af5128a elementor-widget elementor-widget-text-editor\" data-id=\"af5128a\" 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<p style=\"font-weight: 400;\">A veces llamado \u201cuso compasivo\u201d, el acceso ampliado es una v\u00eda potencial para un paciente con una\u00a0<a href=\"https:\/\/www.fda.gov\/news-events\/expanded-access\/expanded-access-keywords-definitions-and-resources\">condici\u00f3n que amenaza inmediatamente la vida o enfermedad o condici\u00f3n grave<\/a>\u00a0para acceder a un\u00a0<a href=\"https:\/\/www.fda.gov\/news-events\/expanded-access\/expanded-access-keywords-definitions-and-resources\">producto m\u00e9dico en investigaci\u00f3n<\/a>\u00a0(medicamento, biol\u00f3gico o dispositivo m\u00e9dico) para tratamiento fuera de ensayos cl\u00ednicos cuando no hay opciones de terapia alternativas comparables o satisfactorias disponibles.\u00a0<\/p><p style=\"font-weight: 400;\">Nanoscope Therapeutics, Inc. se centra en el avance exitoso de su f\u00e1rmaco en investigaci\u00f3n, MCO-010, a trav\u00e9s del proceso regulatorio para la retinosis pigmentaria y la enfermedad de Stargardt, ya que sabemos que esto permitir\u00e1 que el mayor n\u00famero de pacientes tenga acceso a nuestros medicamentos en el menor tiempo posible. Adem\u00e1s, la seguridad y la eficacia de nuestros f\u00e1rmacos en investigaci\u00f3n, as\u00ed como las t\u00e9cnicas \u00f3ptimas de administraci\u00f3n, a\u00fan no se han establecido por completo. Por lo tanto, Nanoscope Therapeutics no suele ofrecer acceso ampliado a sus f\u00e1rmacos en investigaci\u00f3n, sino que anima a los pacientes a consultar con sus m\u00e9dicos sobre su elegibilidad para participar en cualquiera de nuestros ensayos cl\u00ednicos que puedan tener un impacto positivo en su enfermedad.<\/p><p style=\"font-weight: 400;\">Sin embargo, en casos excepcionales, podemos considerar solicitudes de m\u00e9dicos con licencia en EE. UU. para sus pacientes con retinosis pigmentaria o enfermedad de Stargardt que hayan agotado todas las terapias alternativas viables. Las solicitudes de acceso ampliado deben provenir del m\u00e9dico tratante y enviarse por correo electr\u00f3nico a: <a href=\"mailto:info@nanostherapeutics.com\">info@nanostherapeutics.com<\/a>. Intentaremos responder a dichas solicitudes dentro de los 10 d\u00edas h\u00e1biles.<\/p><p style=\"font-weight: 400;\">Nanoscope Therapeutics considerar\u00e1 los siguientes factores para un posible uso compasivo:<\/p><ul style=\"font-weight: 400;\"><li>La situaci\u00f3n cl\u00ednica del paciente, incluido si se han agotado todas las opciones de terapia o ensayo cl\u00ednico aprobadas.<\/li><li>Si el m\u00e9dico tratante cree que los beneficios potenciales de nuestro f\u00e1rmaco en investigaci\u00f3n superar\u00e1n cualquier riesgo potencial para el paciente.<\/li><li>La capacidad del m\u00e9dico tratante para comunicar adecuadamente al paciente los riesgos y beneficios potenciales del uso propuesto de nuestro medicamento en investigaci\u00f3n para que el paciente pueda brindar su consentimiento informado y la voluntad de todas las partes de firmar una autorizaci\u00f3n.\u00a0<\/li><li>La capacidad del m\u00e9dico tratante para administrar nuestro f\u00e1rmaco en investigaci\u00f3n mediante inyecci\u00f3n intrav\u00edtrea que se est\u00e1 estableciendo en nuestros ensayos cl\u00ednicos.<\/li><li>La probabilidad de que las autoridades reguladoras y las juntas de revisi\u00f3n institucional (IRB) revisen y aprueben la ampliaci\u00f3n del acceso para el paciente de manera oportuna.<\/li><li>Nuestra experiencia pasada con el IRB del sitio y el compromiso del m\u00e9dico tratante de obtener la aprobaci\u00f3n del IRB y mantener una solicitud de nuevo medicamento en investigaci\u00f3n (IND)<\/li><li>El suministro disponible de un f\u00e1rmaco en investigaci\u00f3n.<\/li><li>El impacto de brindar un mayor acceso a los recursos dedicados a nuestros programas de desarrollo\u00a0<\/li><li>Otros factores que podamos considerar apropiados<\/li><\/ul><p style=\"font-weight: 400;\">Nanoscope Therapeutics, Inc. se reserva el derecho de revisar o suspender esta pol\u00edtica sin previo aviso.<\/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>Nanoscope Therapeutics, Inc. Expanded Access Policy Sometimes called \u201ccompassionate use\u201d, expanded access is a potential pathway for a patient with an\u00a0immediately life-threatening condition or serious disease or condition\u00a0to gain access to an\u00a0investigational medical product\u00a0(drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.\u00a0 Nanoscope [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":8971,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-8951","page","type-page","status-publish","has-post-thumbnail","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Compassionate Use Policy - 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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