{"id":7766,"date":"2020-12-30T07:08:38","date_gmt":"2020-12-30T07:08:38","guid":{"rendered":"https:\/\/www.nicox.com\/nicox-initiation-dune-etude-clinique-de-phase-3-pour-zerviate-en-chine-par-son-partenaire-ocumension-therapeutics-2\/"},"modified":"2020-12-30T07:08:38","modified_gmt":"2020-12-30T07:08:38","slug":"nicox-initiation-dune-etude-clinique-de-phase-3-pour-zerviate-en-chine-par-son-partenaire-ocumension-therapeutics-2","status":"publish","type":"post","link":"https:\/\/www.nicox.com\/fr\/nicox-initiation-dune-etude-clinique-de-phase-3-pour-zerviate-en-chine-par-son-partenaire-ocumension-therapeutics-2\/","title":{"rendered":"Nicox : Initiation d\u2019une \u00e9tude clinique de phase 3 pour ZERVIATE en Chine par son partenaire Ocumension Therapeutics"},"content":{"rendered":"<p>Sophia Antipolis, France<\/p>\n<p><strong>Nicox SA<\/strong> (Euronext Paris : FR0013018124, COX), soci\u00e9t\u00e9 internationale sp\u00e9cialis\u00e9e en ophtalmologie, annonce aujourd\u2019hui que son partenaire Ocumension Therapeutics a initi\u00e9 une \u00e9tude clinique de phase 3 en Chine pour ZERVIATE<sup>TM<\/sup>, la premi\u00e8re et unique formulation oculaire topique de l\u2019antihistaminique c\u00e9tirizine pour le traitement du prurit oculaire associ\u00e9 aux conjonctivites allergiques.<\/p>\n<p><strong>Gavin Spencer, Chief Business Officer de Nicox<\/strong>, a d\u00e9clar\u00e9:<em> \u201cNos \u00e9quipes ont collabor\u00e9 \u00e9troitement pour obtenir l\u2019autorisation de cette \u00e9tude clinique en Chine et nous sommes heureux qu\u2019en cons\u00e9quence Ocumension ait pu initier rapidement l\u2019\u00e9tude. Cette \u00e9tude de phase 3, en plus de l\u2019ensemble des donn\u00e9es utilis\u00e9es par la FDA pour ZERVIATE aux \u00c9tats-Unis, pourraient \u00eatre suffisants pour une demande d\u2019autorisation de mise sur le march\u00e9 en Chine. L\u2019initiation de cette \u00e9tude s\u2019inscrit dans le calendrier d\u2019Ocumension pour le lancement en Chine.<\/em><\/p>\n<p>L\u2019\u00e9tude clinique de phase 3 est une \u00e9tude randomis\u00e9e, multicentrique, en groupes parall\u00e8les versus comparateur, avec investigateur en simple aveugle visant \u00e0 \u00e9valuer la s\u00e9curit\u00e9 et l\u2019efficacit\u00e9 de ZERVIATE pour les patients chinois atteints de conjonctivite allergique. Environ 296 patients devraient \u00eatre recrut\u00e9s dans approximativement 15 centres cliniques.<\/p>\n<p>Le communiqu\u00e9 de presse publi\u00e9 par Ocumension est disponible sur ce <a href=\"https:\/\/www1.hkexnews.hk\/listedco\/listconews\/sehk\/2020\/1229\/2020122901274.pdf\">lien<\/a>:<\/p>\n<p>ZERVIATE<sup>TM<\/sup> (solution ophtalmique de c\u00e9tirizine), 0,24% est la premi\u00e8re et unique formulation oculaire topique de l\u2019antihistaminique c\u00e9tirizine. ZERVIATE fait l\u2019objet d\u2019un accord de concession de licence exclusif avec Ocumension Therapeutics pour le march\u00e9 chinois et les march\u00e9s d\u2019Asie du Sud Est. Nicox pourrait potentiellement recevoir d\u2019Ocumension des paiements d\u2019\u00e9tape li\u00e9s au d\u00e9veloppement et aux ventes d\u2019un montant pouvant atteindre jusqu\u2019\u00e0 19 millions de dollars ainsi que des redevances de 5% \u00e0 9% sur les ventes nettes de ZERVIATE.<\/p>\n<p>ZERVIATE, commercialis\u00e9 aux Etats-Unis en mars 2020 par Eyevance Pharmaceuticals, le partenaire am\u00e9ricain exclusif de Nicox, fait \u00e9galement l\u2019objet d\u2019accords de concession de licence exclusifs avec Samil Pharmaceutical en Cor\u00e9e du Sud et ITROM Pharmaceutical Group dans les Etats Arabes du Golfe.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sophia Antipolis, France Nicox SA (Euronext Paris : FR0013018124, COX), soci\u00e9t\u00e9 internationale sp\u00e9cialis\u00e9e en ophtalmologie, annonce aujourd\u2019hui que son partenaire Ocumension Therapeutics a initi\u00e9 une \u00e9tude clinique de phase 3 en Chine pour ZERVIATETM, la premi\u00e8re et unique formulation oculaire topique de l\u2019antihistaminique c\u00e9tirizine pour le traitement du prurit oculaire associ\u00e9 aux conjonctivites allergiques. Gavin [&hellip;]<\/p>\n","protected":false},"author":7,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[32,16],"tags":[],"class_list":["post-7766","post","type-post","status-publish","format-standard","hentry","category-actualites","category-actualites-et-media"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Nicox : Initiation d\u2019une \u00e9tude clinique de phase 3 pour ZERVIATE en Chine par son partenaire Ocumension Therapeutics - Nicox<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.nicox.com\/fr\/nicox-initiation-dune-etude-clinique-de-phase-3-pour-zerviate-en-chine-par-son-partenaire-ocumension-therapeutics-2\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Nicox : Initiation d\u2019une \u00e9tude clinique de phase 3 pour ZERVIATE en Chine par son partenaire Ocumension Therapeutics - Nicox\" \/>\n<meta property=\"og:description\" content=\"Sophia Antipolis, France Nicox SA (Euronext Paris : FR0013018124, COX), soci\u00e9t\u00e9 internationale sp\u00e9cialis\u00e9e en ophtalmologie, annonce aujourd\u2019hui que son partenaire Ocumension Therapeutics a initi\u00e9 une \u00e9tude clinique de phase 3 en Chine pour ZERVIATETM, la premi\u00e8re et unique formulation oculaire topique de l\u2019antihistaminique c\u00e9tirizine pour le traitement du prurit oculaire associ\u00e9 aux conjonctivites allergiques. 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