{"id":4324,"date":"2025-02-12T06:30:35","date_gmt":"2025-02-12T11:30:35","guid":{"rendered":"https:\/\/www.gensight-biologics.com\/gensight-biologics-annonce-les-resultats-defficacite-et-de-securite-a-cinq-ans-de-la-therapie-genique-lumevoq-a-lissue-de-letude-reflect\/"},"modified":"2026-09-24T00:05:47","modified_gmt":"2026-09-24T04:05:47","slug":"gensight-biologics-annonce-les-resultats-defficacite-et-de-securite-a-cinq-ans-de-la-therapie-genique-lumevoq-a-lissue-de-letude-reflect","status":"publish","type":"post","link":"https:\/\/www.gensight-biologics.com\/fr\/2025\/02\/12\/gensight-biologics-annonce-les-resultats-defficacite-et-de-securite-a-cinq-ans-de-la-therapie-genique-lumevoq-a-lissue-de-letude-reflect\/","title":{"rendered":"GenSight Biologics annonce les r\u00e9sultats d’efficacit\u00e9 et de s\u00e9curit\u00e9 \u00e0 cinq ans de la th\u00e9rapie g\u00e9nique LUMEVOQ\u00ae \u00e0 l’issue de l’\u00e9tude REFLECT"},"content":{"rendered":"\nParis, France, le<\/strong> 12\u00a0f\u00e9vrier\u00a02025, 7h30 CET<\/strong> \u2014 GenSight Biologics (Euronext\u00a0: SIGHT, ISIN\u00a0: FR0013183985, \u00e9ligible au PEA-PME), une soci\u00e9t\u00e9 biopharmaceutique sp\u00e9cialis\u00e9e dans le d\u00e9veloppement et la commercialisation de th\u00e9rapies g\u00e9niques innovantes pour les maladies r\u00e9tiniennes neurod\u00e9g\u00e9n\u00e9ratives et les troubles du syst\u00e8me nerveux central, a publi\u00e9 aujourd\u2019hui les r\u00e9sultats d\u2019efficacit\u00e9 et de s\u00e9curit\u00e9 \u00e0 5\u00a0ans apr\u00e8s l\u2019administration du traitement \u00e0 l’issue de l’essai de l\u2019\u00e9tude de phase III REFLECT, portant sur LUMEVOQ\u00ae <\/sup>(GS010\u00a0; lenadogene nolparvovec). Les r\u00e9sultats montrent que cinq ans apr\u00e8s une administration unique de la th\u00e9rapie g\u00e9nique, l’am\u00e9lioration de l’acuit\u00e9 visuelle chez les patients atteints de NOHL (Neuropathie Optique H\u00e9r\u00e9ditaire de Leber) s’est maintenue avec un profil de s\u00e9curit\u00e9 favorable. L\u2019injection bilat\u00e9rale a eu un effet additionnel par rapport au traitement unilat\u00e9ral, d\u00e9montr\u00e9 dans certaines analyses des taux de r\u00e9ponses.\n\n\u00ab\u00a0Les derni\u00e8res donn\u00e9es de l\u2019\u00e9tude REFLECT confirment que l\u2019am\u00e9lioration observ\u00e9e avec lenadogene nolparvovec se maintient 5\u00a0ans apr\u00e8s l\u2019administration du traitement, ainsi que le b\u00e9n\u00e9fice suppl\u00e9mentaire observ\u00e9 chez les participants recevant une injection intravitr\u00e9enne bilat\u00e9rale de th\u00e9rapie g\u00e9nique<\/em>\u00a0\u00bb, a d\u00e9clar\u00e9 Patrick Yu-Wai-Man, MD, PhD<\/strong>, professeur d’ophtalmologie et consultant honoraire en neuro-ophtalmologie \u00e0 l’universit\u00e9 de Cambridge, au Moorfields Eye Hospital et \u00e0 l’UCL Institute of Ophthalmology, Royaume-Uni, et investigateur principal international de REFLECT.\n\n\u00ab\u00a0Par ailleurs, les participants de l\u2019\u00e9tude REFLECT ayant re\u00e7u une injection bilat\u00e9rale pr\u00e9sentaient un profil de s\u00e9curit\u00e9 comparable aux participants trait\u00e9s unilat\u00e9ralement<\/em>.\u00a0\u00bb\n\nLes observations renforcent les r\u00e9sultats observ\u00e9s \u00e0 4\u00a0ans apr\u00e8s l\u2019administration du traitement rapport\u00e9s en Mars 2024<\/a>.\n\nEfficacit\u00e9 durable et significative \u00e0 l\u2019Ann\u00e9e 5<\/u><\/strong>\n\nL\u2019\u00e9volution de l\u2019acuit\u00e9 visuelle au fil du temps montre que l\u2019am\u00e9lioration visuelle apr\u00e8s traitement par lenadogene nolparvovec s\u2019est maintenue sur 5\u00a0ans chez tous les patients. L\u2019am\u00e9lioration des yeux des patients ayant re\u00e7u le placebo met en \u00e9vidence l\u2019effet controlat\u00e9ral du traitement constamment observ\u00e9 dans toutes les \u00e9tudes cliniques (\u00e9galement document\u00e9 dans les yeux trait\u00e9s par sham dans les \u00e9tudes REVERSE1<\/sup>\u00a0et RESCUE2<\/sup>). (Voir Graphique 1.)\n\nGraphique\u00a01\u00a0: \u00c9volution de la meilleure acuit\u00e9 visuelle corrig\u00e9e (BCVA) au fil du temps \u2014 \u00c9tude REFLECT de phase III<\/strong>\n\n\"\"\n\n\"\"\n\n# <\/sup>L\u2019imputation de la derni\u00e8re observation report\u00e9e (LOCF) a \u00e9t\u00e9 en accord avec le plan d\u2019analyse statistique (SAP). <\/em>Les donn\u00e9es imput\u00e9es\/non imput\u00e9es ont \u00e9t\u00e9 appliqu\u00e9es aux deux yeux par patient. Gel de la base de donn\u00e9es.\u00a0: 31 d\u00e9cembre 2024.<\/em>\n\nEn raison de la s\u00e9v\u00e9rit\u00e9 de la phase aigu\u00eb de la Neuropathie Optique H\u00e9r\u00e9ditaire de Leber (NOHL), la vision peut encore se d\u00e9t\u00e9riorer au d\u00e9but de l\u2019\u00e9tude jusqu’\u00e0 un point bas ou nadir. Cette caract\u00e9ristique de la maladie fait du nadir observ\u00e9 (c’est-\u00e0-dire la plus faible BCVA enregistr\u00e9e entre l\u2019inclusion et la cinqui\u00e8me ann\u00e9e) un meilleur point de r\u00e9f\u00e9rence pour \u00e9valuer l’effet de la th\u00e9rapie que la vision \u00e0 la\u00a0Baseline<\/em>, qui varie consid\u00e9rablement en fonction du stade de la maladie au moment de\u00a0l\u2019inclusion\u00a0dans l\u2019\u00e9tude. Par rapport au nadir observ\u00e9, l\u2019acuit\u00e9 visuelle moyenne de tous les yeux trait\u00e9s par LUMEVOQ\u00ae a d\u00e9pass\u00e9 le seuil de +15 lettres (changement de -0,3 LogMAR), qui d\u00e9finit conventionnellement une am\u00e9lioration cliniquement significative (voir Tableau 1).\n\nLes analyses des r\u00e9pondeurs renforcent l\u2019observation d\u2019une am\u00e9lioration des r\u00e9sultats pour les patients, pour lesquels l\u2019histoire naturelle entra\u00eene g\u00e9n\u00e9ralement une d\u00e9ficience visuelle s\u00e9v\u00e8re avec une tr\u00e8s faible probabilit\u00e9 de r\u00e9cup\u00e9ration spontan\u00e9e.\u00b3 Cinq ans apr\u00e8s l\u2019injection, les patients ayant re\u00e7u le traitement bilat\u00e9ral ont pr\u00e9sent\u00e9 un taux plus \u00e9lev\u00e9 de r\u00e9cup\u00e9ration cliniquement significative* depuis leur nadir, compar\u00e9 aux patients ayant re\u00e7u le traitement unilat\u00e9ral (75 % contre 60 %). 79 % des patients trait\u00e9s bilat\u00e9ralement \u00e9taient en mesure de lire des lettres sur un \u00e9cran (vision \u00ab\u00a0on chart<\/em>\u00a0\u00bb), contre 72 % des patients trait\u00e9s unilat\u00e9ralement.\n\nTableau 1\u00a0: Variation de la meilleure acuit\u00e9 visuelle corrig\u00e9e (BCVA) par rapport au nadir 5\u00a0ans apr\u00e8s l\u2019injection<\/strong>\n\n\n\n\n\n
<\/td>\n1er<\/sup> \u0153il atteint<\/strong><\/td>\n2e<\/sup> \u0153il atteint<\/strong><\/td>\n<\/tr>\n
Patients ayant re\u00e7u une injection bilat\u00e9rale de LUMEVOQ\u00ae<\/sup><\/strong><\/td>\nLUMEVOQ\u00ae<\/sup><\/strong>\n\n–0.38 LogMAR\n<\/strong>+19 <\/strong>lettres ETDRS<\/strong><\/td>\nLUMEVOQ\u00ae<\/sup><\/strong>\n\n-0.35 LogMAR\n<\/strong>+18 <\/strong>lettres ETDRS<\/strong><\/td>\n<\/tr>\n
Patients ayant re\u00e7u une injection unilat\u00e9rale de LUMEVOQ\u00ae<\/sup><\/strong><\/td>\nLUMEVOQ\u00ae<\/sup><\/strong>\n\n-0.40 LogMAR\n<\/strong>+20 <\/strong>lettres ETDRS<\/strong><\/td>\nPLACEBO\n\n-0.28 LogMAR\n+14 lettres ETDRS<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\nDate du gel de la base de donn\u00e9es\u00a0: 31 d\u00e9cembre\u00a02024. Patients trait\u00e9s bilat\u00e9ralement\u00a0: 1er<\/sup> \u0153il affect\u00e9\u00a0: n=48\u00a0; 2e<\/sup> \u0153il affect\u00e9\u00a0: n=48\u00a0; patients trait\u00e9s unilat\u00e9ralement\u00a0: 1er<\/sup> \u0153il affect\u00e9\u00a0: n=50\u00a0; 2e<\/sup> \u0153il affect\u00e9\u00a0: n=50. p<0,0001 pour tous les groupes d\u2019yeux bas\u00e9 sur un mod\u00e8le mixte lin\u00e9aire.<\/em>\n\nProfil de s\u00e9curit\u00e9 favorable<\/u><\/strong>\n\nLe profil de s\u00e9curit\u00e9 favorable de LUMEVOQ\u00ae<\/sup> a continu\u00e9 \u00e0 \u00eatre confirm\u00e9 et a \u00e9t\u00e9 d\u00e9montr\u00e9 comme \u00e9tant comparable chez les patients trait\u00e9s bilat\u00e9ralement et unilat\u00e9ralement. Aucun arr\u00eat d\u2019\u00e9tude li\u00e9 \u00e0 des \u00e9v\u00e9nements ind\u00e9sirables syst\u00e9miques ou oculaires et aucun \u00e9v\u00e9nement ind\u00e9sirable oculaire grave n\u2019ont \u00e9t\u00e9 enregistr\u00e9s. Le principal \u00e9v\u00e9nement ind\u00e9sirable oculaire \u00e9tait une inflammation intraoculaire, g\u00e9n\u00e9ralement l\u00e9g\u00e8re, et r\u00e9pondant au traitement conventionnel.\n\nREFLECT \u00e9tait une \u00e9tude de phase III randomis\u00e9e, en double insu, contr\u00f4l\u00e9e contre placebo, incluant 98\u00a0patients pr\u00e9sentant une perte visuelle due \u00e0 une neuropathie optique h\u00e9r\u00e9ditaire de Leber (NOHL) caus\u00e9e par un g\u00e8ne mitochondrial ND4<\/em> mut\u00e9\u00a0; les patients ND4<\/em> inclus pr\u00e9sentaient une perte visuelle jusqu\u2019\u00e0 un an depuis son apparition. Tous les patients ont re\u00e7u une injection intravitr\u00e9enne (IVT) de lenadogene nolparvovec dans leur premier \u0153il affect\u00e9. Le deuxi\u00e8me \u0153il affect\u00e9 a \u00e9t\u00e9 randomis\u00e9 pour recevoir une deuxi\u00e8me IVT de LUMEVOQ\u00ae<\/sup> ou une IVT de placebo, qui a \u00e9t\u00e9 administr\u00e9e le m\u00eame jour ou le jour suivant. 48\u00a0patients ont \u00e9t\u00e9 randomis\u00e9s pour recevoir un traitement bilat\u00e9ral par LUMEVOQ\u00ae<\/sup>, et 50 pour recevoir un traitement unilat\u00e9ral par lenadogene nolparvovec (premier \u0153il affect\u00e9 trait\u00e9 par LUMEVOQ\u00ae<\/sup>, deuxi\u00e8me \u0153il affect\u00e9 trait\u00e9 par placebo). Les patients REFLECT ont \u00e9t\u00e9 suivis jusqu\u2019\u00e0 5\u00a0ans apr\u00e8s l\u2019injection.\n\n*La \u00ab\u00a0r\u00e9cup\u00e9ration cliniquement pertinente\u00a0\u00bb, ou CRR<\/em> (Clinically Relevant Recovery<\/em>), d\u00e9signe une am\u00e9lioration de la meilleure acuit\u00e9 visuelle corrig\u00e9e (BCVA\u00a0: Best Corrected Visual Acuity<\/em>) r\u00e9pondant \u00e0 l\u2019une des deux conditions suivantes\u00a0: (1) Am\u00e9lioration de 10 lettres (\u2265 0,2 LogMAR) pour une acuit\u00e9 visuelle \u00ab\u00a0on-chart\u00a0\u00bb initiale. (2) Passage de \u00ab\u00a0off-chart\u00a0\u00bb \u00e0 \u00ab\u00a0on-chart\u00a0\u00bb (\u22641,6 LogMAR).\n\nR\u00e9f\u00e9rences\u00a0:<\/em><\/strong>\n
    \n \t
  1. Yu-Wai-Man P, Newman NJ, Carelli V, Moster ML, Biousse V, Sadun AA, et al. Bilateral visual improvement with unilateral gene therapy injection for Leber hereditary optic neuropathy. Sci Transl Med.<\/em> (2020) 12:eaaz7423. doi : 10.1126\/scitranslmed.aaz7423<\/li>\n \t
  2. Newman NJ, Yu-Wai-Man P, Carelli V, Moster ML, Biousse V, Vignal-Clermont C, et al. Efficacy and safety of intravitreal gene therapy for Leber hereditary optic neuropathy treated within 6 months of disease onset. Ophthalmology<\/em>. (2021) 128:649\u201360. doi : 10.1016\/j.ophtha.2020.12.012.<\/li>\n \t
  3. Newman NJ, Carelli V, Taiel M, Yu-Wai-Man P. Visual outcomes in Leber hereditary optic neuropathy subjects with the m.11778G>A (MTND4) mitochondrial DNA mutation. J Neuro-Ohthalmol.<\/em> (2020) 40 :547\u201357. doi : 10.1097\/WNO.0000000000001045.<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"
      \n
    • Efficacit\u00e9 maintenue 5\u00a0ans apr\u00e8s l\u2019injection dans le cadre de l\u2019\u00e9tude de phase III REFLECT<\/li>\n
    • Maintien du b\u00e9n\u00e9fice \u00e0 5\u00a0ans chez les patients trait\u00e9s bilat\u00e9ralement\u00a0: am\u00e9lioration cliniquement significative d\u2019au moins 15\u00a0lettres par rapport \u00e0 leur nadir (acuit\u00e9 visuelle la plus faible)<\/li>\n
    • 75% des patients trait\u00e9s bilat\u00e9ralement ont pr\u00e9sent\u00e9 une R\u00e9cup\u00e9ration Cliniquement Pertinente (CRR)* par rapport \u00e0 leur nadir visuel<\/li>\n
    • Profil de s\u00e9curit\u00e9 favorable confirm\u00e9 \u00e0 5\u00a0ans<\/li>\n<\/ul>\n","protected":false},"author":10,"featured_media":5697,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":"","_links_to":"","_links_to_target":""},"categories":[54],"tags":[],"featured-area":[],"news-topic":[73],"news-type":[74,75],"post-year":[],"class_list":["post-4324","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-communiques-de-presse-financiers","news-topic-gs010-lumevoq","news-type-product-candidates","news-type-clinical"],"acf":[],"yoast_head":"\nGenSight Biologics annonce les r\u00e9sultats d'efficacit\u00e9 et de s\u00e9curit\u00e9 \u00e0 cinq ans de la th\u00e9rapie g\u00e9nique LUMEVOQ\u00ae \u00e0 l'issue de l'\u00e9tude REFLECT - GenSight Biologics<\/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.gensight-biologics.com\/fr\/2025\/02\/12\/gensight-biologics-annonce-les-resultats-defficacite-et-de-securite-a-cinq-ans-de-la-therapie-genique-lumevoq-a-lissue-de-letude-reflect\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"GenSight Biologics annonce les r\u00e9sultats d'efficacit\u00e9 et de s\u00e9curit\u00e9 \u00e0 cinq ans de la th\u00e9rapie g\u00e9nique LUMEVOQ\u00ae \u00e0 l'issue de l'\u00e9tude REFLECT - GenSight Biologics\" \/>\n<meta property=\"og:description\" content=\"Efficacit\u00e9 maintenue 5\u00a0ans apr\u00e8s l\u2019injection dans le cadre de l\u2019\u00e9tude de phase III REFLECT Maintien du b\u00e9n\u00e9fice \u00e0 5\u00a0ans chez les patients trait\u00e9s bilat\u00e9ralement\u00a0: am\u00e9lioration cliniquement significative d\u2019au moins 15\u00a0lettres par rapport \u00e0 leur nadir (acuit\u00e9 visuelle la plus faible) 75% des patients trait\u00e9s bilat\u00e9ralement ont pr\u00e9sent\u00e9 une R\u00e9cup\u00e9ration Cliniquement Pertinente (CRR)* par rapport \u00e0 leur nadir visuel Profil de s\u00e9curit\u00e9 favorable confirm\u00e9 \u00e0 5\u00a0ans\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.gensight-biologics.com\/fr\/2025\/02\/12\/gensight-biologics-annonce-les-resultats-defficacite-et-de-securite-a-cinq-ans-de-la-therapie-genique-lumevoq-a-lissue-de-letude-reflect\/\" \/>\n<meta property=\"og:site_name\" content=\"GenSight Biologics\" \/>\n<meta property=\"article:published_time\" content=\"2025-02-12T11:30:35+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2026-09-24T04:05:47+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/www.gensight-biologics.com\/wp-content\/uploads\/2026\/07\/REFLECT-Year-5-FIGURE-CURVES.png\" \/>\n\t<meta property=\"og:image:width\" content=\"640\" \/>\n\t<meta property=\"og:image:height\" 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