{"id":7726,"date":"2020-09-22T05:33:35","date_gmt":"2020-09-22T05:33:35","guid":{"rendered":"https:\/\/www.nicox.com\/nicox-approbation-de-la-demande-dautorisation-detude-clinique-pour-zerviate-en-chine\/"},"modified":"2020-09-22T05:33:35","modified_gmt":"2020-09-22T05:33:35","slug":"nicox-approbation-de-la-demande-dautorisation-detude-clinique-pour-zerviate-en-chine","status":"publish","type":"post","link":"https:\/\/www.nicox.com\/fr\/nicox-approbation-de-la-demande-dautorisation-detude-clinique-pour-zerviate-en-chine\/","title":{"rendered":"Nicox : Approbation de la demande d\u2019autorisation d\u2019\u00e9tude clinique pour ZERVIATE en Chine"},"content":{"rendered":"<p>Sophia Antipolis, France<\/p>\n<p><strong>Nicox SA<\/strong> (Euronext Paris : FR0013018124, COX, \u00e9ligible PEA-PME), soci\u00e9t\u00e9 internationale sp\u00e9cialis\u00e9e en ophtalmologie, annonce aujourd\u2019hui que son partenaire Ocumension Therapeutics a re\u00e7u l\u2019approbation des autorit\u00e9s r\u00e9glementaires chinoises (<em>Center for Drug Evaluation of the National Medical Products Administration<\/em>) pour mener des \u00e9tudes cliniques de phase 3 sur ZERVIATE<sup>TM<\/sup> (solution ophtalmique de c\u00e9tirizine), 0,24% pour le traitement du prurit oculaire associ\u00e9 aux conjonctivites allergiques. ZERVIATE, la premi\u00e8re formulation oculaire topique de c\u00e9tirizine, fait l\u2019objet d\u2019un accord de concession exclusif avec Ocumension Therapeutics pour le march\u00e9 chinois et la majorit\u00e9 des march\u00e9s d\u2019Asie du Sud-Est. Le d\u00e9marrage de l\u2019\u00e9tude de phase 3 est attendu au quatri\u00e8me trimestre 2020.<\/p>\n<p><strong>Dr. Jos\u00e9 Boyer, <em>Vice President and Head, Clinical Development<\/em> de <\/strong><strong>Nicox<\/strong>, a d\u00e9clar\u00e9 :<em> \u201cLa collaboration efficace entre les \u00e9quipes de d\u00e9veloppement d\u2019Ocumension et de Nicox a permis la soumission de cette demande d\u2019autorisation d\u2019\u00e9tude clinique en Chine. Son approbation ouvre la voie \u00e0 un programme de phase 3 en vue d\u2019une approbation d\u2019autorisation de mise sur le march\u00e9 chinois. Nous continuerons d\u2019apporter notre soutien \u00e0 Ocumension dans les prochaines \u00e9tapes vers une commercialisation de ZERVIATE dans ce territoire.\u201d<\/em><\/p>\n<p>Le communiqu\u00e9 de presse publi\u00e9 par Ocumension est disponible sur <a href=\"https:\/\/www1.hkexnews.hk\/listedco\/listconews\/sehk\/2020\/0922\/2020092200013.pdf\">https:\/\/www1.hkexnews.hk\/listedco\/listconews\/sehk\/2020\/0922\/2020092200013.pdf<\/a>.<\/p>\n<p><strong>A propos de ZERVIATE<\/strong><\/p>\n<p>ZERVIATE<sup>TM<\/sup> (solution ophtalmique de c\u00e9tirizine), 0,24%, est une nouvelle formulation de c\u00e9tirizine d\u00e9velopp\u00e9e et approuv\u00e9e pour la premi\u00e8re fois pour une application topique oculaire pour le traitement du prurit oculaire associ\u00e9 aux conjonctivites allergiques. La c\u00e9tirizine, le principe actif du ZYRTEC<sup>\u00ae<\/sup>, est un antihistaminique de deuxi\u00e8me g\u00e9n\u00e9ration (antagoniste du r\u00e9cepteur H1) qui se lie de mani\u00e8re comp\u00e9titive aux sites r\u00e9cepteurs d\u2019histamine. La c\u00e9tirizine, dans des formulations orales approuv\u00e9es, a une efficacit\u00e9 et un profil de s\u00e9curit\u00e9 syst\u00e9miques bien identifi\u00e9s, avec une exposition \u00e0 l\u2019\u00e9chelle mondiale repr\u00e9sentant 20 ann\u00e9es d\u2019utilisation par voie orale. ZERVIATE a \u00e9t\u00e9 d\u00e9velopp\u00e9 par Nicox comme la premi\u00e8re et unique formulation de c\u00e9tirizine pour une application oculaire topique.<\/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<p><strong>A propos de la conjonctivite allergique <\/strong>La conjonctivite allergique se produit lorsqu\u2019une r\u00e9action allergique provoque une conjonctivite. La conjonctivite est une inflammation de la fine membrane qui recouvre le blanc de l\u2019\u0153il et l\u2019int\u00e9rieur des paupi\u00e8res. Cette maladie ophtalmique peut affecter un \u0153il ou les deux yeux. Les sympt\u00f4mes peuvent inclure des rougeurs, des larmoiements excessifs, des br\u00fblures ou des d\u00e9mangeaisons, des s\u00e9cr\u00e9tions oculaires, une vision floue et une sensibilit\u00e9 accrue \u00e0 la lumi\u00e8re.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sophia Antipolis, France Nicox SA (Euronext Paris : FR0013018124, COX, \u00e9ligible PEA-PME), soci\u00e9t\u00e9 internationale sp\u00e9cialis\u00e9e en ophtalmologie, annonce aujourd\u2019hui que son partenaire Ocumension Therapeutics a re\u00e7u l\u2019approbation des autorit\u00e9s r\u00e9glementaires chinoises (Center for Drug Evaluation of the National Medical Products Administration) pour mener des \u00e9tudes cliniques de phase 3 sur ZERVIATETM (solution ophtalmique de c\u00e9tirizine), [&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-7726","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 - 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