{"id":164766,"date":"2025-09-26T12:01:00","date_gmt":"2025-09-26T12:01:00","guid":{"rendered":"https:\/\/v2.optiknow.ca\/essilor-stellest-fda-autorisation\/"},"modified":"2025-09-26T12:01:00","modified_gmt":"2025-09-26T12:01:00","slug":"essilor-stellest-fda-autorisation","status":"publish","type":"post","link":"https:\/\/v2.optiknow.ca\/fr\/2025\/09\/26\/essilor-stellest-fda-autorisation\/","title":{"rendered":"Le verre de myopie Essilor Stellest obtient l\u0092autorisation de la FDA aux \u00c9tats-Unis"},"content":{"rendered":"\n<p>EssilorLuxottica a annonc\u00e9 que la Food and Drug Administration (FDA) des \u00c9tats-Unis a accord\u00e9 une autorisation de mise sur le march\u00e9 pour son verre Essilor Stellest, dans le cadre du processus De Novo.<\/p>\n\n\n\n<p>La classification De Novo pour les dispositifs m\u00e9dicaux est une voie r\u00e9glementaire permettant \u00e0 des dispositifs nouveaux, \u00e0 risque mod\u00e9r\u00e9, d'obtenir une autorisation de commercialisation lorsqu'aucun dispositif \u00e9quivalent n'est disponible pour comparaison.<\/p>\n\n\n\n<p>Le verre Stellest, con\u00e7u pour la gestion de la myopie chez l'enfant, avait d\u00e9j\u00e0 obtenu en 2021 la d\u00e9signation de \u00ab Breakthrough Device \u00bb (Dispositif Innovant) par la FDA. Il devient ainsi le premier verre de lunettes \u00e0 recevoir une autorisation de la FDA sur la base de donn\u00e9es cliniques d\u00e9montrant sa capacit\u00e9 \u00e0 ralentir la progression de la myopie.<\/p>\n\n\n\n<p>Selon les r\u00e9sultats publi\u00e9s, le verre a ralenti la progression de la myopie de 71 % en moyenne sur deux ans lors d'essais cliniques. D\u00e9j\u00e0 introduit sur plusieurs march\u00e9s internationaux, il sera mis \u00e0 la disposition des professionnels de la vue aux \u00c9tats-Unis dans les prochaines semaines.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Diff\u00e9rences r\u00e9glementaires : Canada vs \u00c9tats-Unis<\/strong><\/h3>\n\n\n\n<p>Le processus r\u00e9glementaire am\u00e9ricain pour les verres de contr\u00f4le de la myopie a \u00e9t\u00e9 plus long qu'au Canada. Jusqu'\u00e0 pr\u00e9sent, les professionnels de la vue am\u00e9ricains ne pouvaient prescrire ce type de verres qu'\u00ab hors indication \u00bb, aucun produit n'ayant encore re\u00e7u d'autorisation sp\u00e9cifique de la FDA.<\/p>\n\n\n\n<p>Au Canada, les autorit\u00e9s de sant\u00e9 ne requi\u00e8rent pas d'approbation r\u00e9glementaire particuli\u00e8re pour la commercialisation de verres de lunettes avec des all\u00e9gations de contr\u00f4le de la myopie. Cela a permis des lancements plus rapides et une adoption plus large de cette cat\u00e9gorie de verres au pays. Les verres Stellest ont \u00e9t\u00e9 lanc\u00e9s au Canada en f\u00e9vrier 2022.<\/p>\n\n\n\n<p>?? <a href=\"https:\/\/www.optiknow.ca\/fr\/?s=stellest\" target=\"_blank\" rel=\"noreferrer noopener\">Consultez d'autres articles sur Stellest dans OptikNOW<\/a><\/p>\n\n\n\n<p><a href=\"https:\/\/www.optiknow.ca\/wp-content\/uploads\/2025\/09\/2025-09-25-essilorluxottica-us-fda-essilor-stellest-market-a-FR.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">Cliquez ICI<\/a> pour le communiqu\u00e9 de presse complet.<\/p>\n\n\n\n<p>Vous voulez voir plus d'articles comme celui-ci? <a href=\"https:\/\/optiknow.ca\/custom-forms\/subscribe-fr.html\" target=\"_blank\" rel=\"noreferrer noopener\">Cliquez ici<\/a> pour vous abonner \u00e0 notre magazine imprim\u00e9 GRATUIT et \u00e0 nos infolettres!<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Le verre Essilor Stellest devient le premier verre de lunettes autoris\u00e9 par la FDA pour ralentir la progression de la myopie chez l\u0092enfant.<\/p>\n","protected":false},"author":1,"featured_media":152875,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[23133],"tags":[27594,27595,27596,23690,23421,27597,27598],"class_list":["post-164766","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-nouvelles","tag-dispositif-medical-de-novo-fda","tag-essilorluxottica-stellest-fda","tag-lancement-essilor-stellest-canada-2022","tag-optometristes","tag-professionnels-de-la-vue","tag-traitement-de-la-myopie-infantile","tag-verre-de-controle-de-la-myopie"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - 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