{"id":20631,"date":"2026-10-12T14:56:55","date_gmt":"2026-10-12T14:56:55","guid":{"rendered":"https:\/\/veilles-affaires-sociales.fr\/?p=20631"},"modified":"2026-10-12T14:56:55","modified_gmt":"2026-10-12T14:56:55","slug":"rapport-europeen-public-devaluation-epar-pour-les-medicaments-a-usage-humain-roclanda-latanoprost-netarsudil-date-dautorisation-07-01-2021-revision-13-statut-autorise","status":"publish","type":"post","link":"https:\/\/veilles-affaires-sociales.fr\/?p=20631","title":{"rendered":"Rapport europ\u00e9en public d\u2019\u00e9valuation (EPAR) pour les m\u00e9dicaments \u00e0 usage humain : Roclanda, latanoprost \/ n\u00e9tarsudil, Date d\u2019autorisation : 07\/01\/2021, R\u00e9vision : 13, Statut : Autoris\u00e9\u00a0(titre traduit en fran\u00e7ais par l&rsquo;IA)"},"content":{"rendered":"<p>Roclanda est un collyre indiqu\u00e9 chez l\u2019adulte pour la r\u00e9duction de la pression intraoculaire en cas de glaucome \u00e0 angle ouvert ou d\u2019hypertension oculaire, lorsque un traitement pr\u00e9alable par une prostaglandine seule ou par le n\u00e9arsudil seul n\u2019a pas permis un contr\u00f4le suffisant de la pression. Le m\u00e9dicament contient deux substances actives, le latanoprost (analogue de la prostaglandine) et le n\u00e9arsudil (inhibiteur de la Rho kinase), qui agissent de fa\u00e7on compl\u00e9mentaire en augmentant l\u2019\u00e9vacuation de l\u2019humeur aqueuse et en diminuant la pression \u00e0 l\u2019int\u00e9rieur de l\u2019\u0153il, afin de pr\u00e9venir les l\u00e9sions r\u00e9tiniennes et du nerf optique pouvant conduire \u00e0 une perte visuelle s\u00e9v\u00e8re voire \u00e0 la c\u00e9cit\u00e9.<\/p>\n<p>Roclanda est soumis \u00e0 prescription m\u00e9dicale et l\u2019instauration du traitement doit \u00eatre r\u00e9alis\u00e9e par un ophtalmologiste. Il est administr\u00e9 sous forme de solution en gouttes ophtalmiques, \u00e0 raison d\u2019une goutte le soir dans l\u2019\u0153il atteint. Pour les modalit\u00e9s pr\u00e9cises d\u2019utilisation, les effets ind\u00e9sirables et les contre-indications, la r\u00e9f\u00e9rence est la notice du m\u00e9dicament ou l\u2019avis du professionnel de sant\u00e9.<\/p>\n<p>Deux \u00e9tudes cliniques principales, portant au total sur 1 468 adultes pr\u00e9sentant un glaucome ou une hypertension oculaire, ont montr\u00e9 que Roclanda r\u00e9duit davantage la pression intraoculaire que chacune de ses substances actives prises s\u00e9par\u00e9ment. La pression intraoculaire a \u00e9t\u00e9 mesur\u00e9e \u00e0 9 reprises sur une p\u00e9riode de 3 mois. Les patients trait\u00e9s par Roclanda pr\u00e9sentaient des pressions moyennes comprises entre 15,03 et 16,38 mmHg, contre 17,35 \u00e0 19,39 mmHg sous n\u00e9arsudil seul et 16,93 \u00e0 17,96 mmHg sous latanoprost seul, ce qui indique un effet additif des deux principes actifs.<\/p>\n<p>Les effets ind\u00e9sirables les plus fr\u00e9quents (plus de 1 patient sur 10) sont une hyper\u00e9mie conjonctivale (\u0153il rouge), des douleurs au site d\u2019instillation et une corn\u00e9e verticill\u00e9e (d\u00e9p\u00f4ts corn\u00e9ens). Parmi les autres effets ind\u00e9sirables fr\u00e9quents (jusqu\u2019\u00e0 1 patient sur 10) figurent prurit oculaire, \u00e9ryth\u00e8me et inconfort oculaires, larmoiement accru et h\u00e9morragie conjonctivale. La liste compl\u00e8te des effets ind\u00e9sirables et des restrictions figure dans la notice. Ces \u00e9l\u00e9ments sont pertinents pour le suivi des strat\u00e9gies th\u00e9rapeutiques en ophtalmologie et l\u2019\u00e9valuation des b\u00e9n\u00e9fices\/risques de nouvelles associations m\u00e9dicamenteuses dans la prise en charge du glaucome et de l\u2019hypertension oculaire. (contenu r\u00e9sum\u00e9 en fran\u00e7ais par l&rsquo;IA)\u00a0\u200b<a href=\"https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/roclanda\" target=\"_blank\" class=\"feedzy-rss-link-icon\">Lire la Suite<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Roclanda est un collyre indiqu\u00e9 chez l\u2019adulte pour la r\u00e9duction de la pression intraoculaire en cas de glaucome \u00e0 angle ouvert ou d\u2019hypertension oculaire, lorsque un traitement pr\u00e9alable par une [&hellip;]<\/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-20631","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\/20631","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=20631"}],"version-history":[{"count":0,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=\/wp\/v2\/posts\/20631\/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=20631"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=20631"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/veilles-affaires-sociales.fr\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=20631"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}