Yesafili est un m\u00e9dicament biologique biosimilaire d\u2019Eylea (substance active : aflibercept), autoris\u00e9 dans l\u2019Union europ\u00e9enne pour le traitement chez l\u2019adulte de plusieurs pathologies oculaires : forme n\u00e9ovasculaire (\u00ab humide \u00bb) de la d\u00e9g\u00e9n\u00e9rescence maculaire li\u00e9e \u00e0 l\u2019\u00e2ge (DMLA), baisse de vision li\u00e9e \u00e0 un \u0153d\u00e8me maculaire cons\u00e9cutif \u00e0 une occlusion veineuse r\u00e9tinienne centrale (CRVO) ou d\u2019une branche veineuse (BRVO), baisse de vision li\u00e9e \u00e0 un \u0153d\u00e8me maculaire diab\u00e9tique, et baisse de vision li\u00e9e \u00e0 une n\u00e9ovascularisation choro\u00efdienne myopique (complication de la myopie forte avec allongement du globe oculaire). <\/p>\n
Le m\u00e9dicament se pr\u00e9sente en flacons contenant une solution pour injection intravitr\u00e9enne (dans le corps vitr\u00e9 de l\u2019\u0153il). Il est soumis \u00e0 prescription m\u00e9dicale et son administration est r\u00e9serv\u00e9e \u00e0 des m\u00e9decins exp\u00e9riment\u00e9s dans la r\u00e9alisation de ces injections. Les injections sont r\u00e9p\u00e9t\u00e9es \u00e0 intervalles d\u2019au moins un mois, la fr\u00e9quence \u00e9tant adapt\u00e9e en fonction de la pathologie trait\u00e9e et de la r\u00e9ponse du patient. <\/p>\n
L\u2019aflibercept est une prot\u00e9ine de fusion con\u00e7ue pour se lier au facteur de croissance de l\u2019endoth\u00e9lium vasculaire A (VEGF-A) et \u00e0 d\u2019autres prot\u00e9ines telles que le facteur de croissance placentaire (PlGF), impliqu\u00e9s dans la stimulation de la croissance anormale de vaisseaux sanguins et dans les ph\u00e9nom\u00e8nes de fuite et d\u2019\u0153d\u00e8me. En neutralisant ces facteurs, Yesafili limite la croissance vasculaire anormale et r\u00e9duit les fuites et le gonflement au niveau de la r\u00e9tine. <\/p>\n
Des \u00e9tudes de laboratoire ont montr\u00e9 que la substance active de Yesafili est hautement similaire \u00e0 celle d\u2019Eylea en termes de structure, de puret\u00e9 et d\u2019activit\u00e9 biologique, et que l\u2019administration de Yesafili entra\u00eene des concentrations syst\u00e9miques comparables \u00e0 celles observ\u00e9es avec Eylea. Une \u00e9tude clinique men\u00e9e chez 355 patients pr\u00e9sentant un \u0153d\u00e8me maculaire diab\u00e9tique a montr\u00e9 des am\u00e9liorations similaires de l\u2019acuit\u00e9 visuelle avec Yesafili et Eylea : apr\u00e8s huit semaines de traitement, le nombre moyen de lettres reconnues lors d\u2019un test standardis\u00e9 de vision s\u2019est am\u00e9lior\u00e9 d\u2019environ sept lettres dans chacun des deux groupes. <\/p>\n
En tant que biosimilaire, Yesafili b\u00e9n\u00e9ficie des donn\u00e9es d\u2019efficacit\u00e9 et de s\u00e9curit\u00e9 d\u00e9j\u00e0 \u00e9tablies pour l\u2019aflibercept avec le m\u00e9dicament de r\u00e9f\u00e9rence Eylea, ce qui limite le besoin d\u2019\u00e9tudes cliniques suppl\u00e9mentaires. Cette mise sur le march\u00e9 dans l\u2019UE d\u2019un biosimilaire dans le domaine de l\u2019ophtalmologie peut pr\u00e9senter un int\u00e9r\u00eat pour le suivi des politiques de ma\u00eetrise des d\u00e9penses de sant\u00e9 et d\u2019acc\u00e8s aux traitements, sans que le document ne fournisse toutefois d\u2019\u00e9l\u00e9ments sp\u00e9cifiques sur les conditions de prix, de remboursement ou d\u2019organisation des soins. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l’IA)\u00a0\u200bLire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":" Yesafili est un m\u00e9dicament biologique biosimilaire d\u2019Eylea (substance active : aflibercept), autoris\u00e9 dans l\u2019Union europ\u00e9enne pour le traitement chez l\u2019adulte de plusieurs pathologies oculaires : forme n\u00e9ovasculaire (\u00ab humide \u00bb) […]<\/p>\n","protected":false},"author":1,"featured_media":17698,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[7],"tags":[257,227,226],"class_list":["post-21437","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medicaments-et-produits-de-sante","tag-ema","tag-ia","tag-sources-etrangeres"],"_links":{"self":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21437","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=21437"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/21437\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/media\/17698"}],"wp:attachment":[{"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=21437"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=21437"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=21437"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}