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Hoffmann-La Roche Ltd.","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100007013","id-type":"DOI","asserted-by":"crossref"}]},{"DOI":"10.13039\/100004328","name":"Genentech, Inc.","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100004328","id-type":"DOI","asserted-by":"crossref"}]},{"name":"Chugai Pharmaceutical Co., Ltd"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Graefes Arch Clin Exp Ophthalmol"],"published-print":{"date-parts":[[2023,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>To evaluate 1-year efficacy, durability, and safety of faricimab among patients from Asian countries in the TENAYA\/LUCERNE trials of neovascular age-related macular degeneration (nAMD).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Treatment-na\u00efve patients with nAMD were randomly assigned (1:1) to faricimab 6.0\u00a0mg up to every 16\u00a0weeks (Q16W), based on disease activity at weeks 20 and 24, or aflibercept 2.0\u00a0mg Q8W. The primary endpoint was change in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44, and 48.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      In the pooled TENAYA\/LUCERNE trials, there were 120 (9.0%) and 1209 (91.0%) patients in the Asian (faricimab\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200961; aflibercept\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u200959) and non-Asian country (faricimab\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009604; aflibercept\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009605) subgroups, respectively. In the Asian country subgroup, mean BCVA change from baseline at the primary endpoint visits was 7.1 (95% CI, 4.3\u20139.8) letters with faricimab and 7.2 (4.4\u201310.0) letters with aflibercept. In non-Asian country patients, mean vision gains were 6.1 (5.2\u20137.1) and 5.7 (4.8\u20136.7) letters with faricimab and aflibercept, respectively. At week 48, 59.6% of Asian country patients in the faricimab group achieved Q16W dosing (vs. 43.9% non-Asian) and 91.2% achieved\u2009\u2265\u2009Q12W dosing (vs. 77.5% non-Asian). Central subfield thickness reductions were similar between the subgroups, with meaningful and similar reductions from baseline observed at the primary endpoint visits and over time. Faricimab was well tolerated in both subgroups, with an acceptable safety profile.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Consistent with the global TENAYA\/LUCERNE findings, faricimab up to Q16W showed sustained visual and anatomical benefits in patients with nAMD from Asian and non-Asian countries.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov identifier: NCT03823287 (TENAYA); NCT03823300 (LUCERNE). Date of registration: January 30, 2019.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1007\/s00417-023-06071-8","type":"journal-article","created":{"date-parts":[[2023,6,9]],"date-time":"2023-06-09T06:02:38Z","timestamp":1686290558000},"page":"3125-3137","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":27,"title":["Efficacy, durability, and safety of faricimab in patients from Asian countries with neovascular age-related macular degeneration: 1-Year subgroup analysis of the TENAYA and LUCERNE trials"],"prefix":"10.1007","volume":"261","author":[{"given":"Kanji","family":"Takahashi","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chui Ming Gemmy","family":"Cheung","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomohiro","family":"Iida","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy Y. 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JAMA Ophthalmol 138:935\u2013942. https:\/\/doi.org\/10.1001\/jamaophthalmol.2020.2443","journal-title":"JAMA Ophthalmol"}],"container-title":["Graefe's Archive for Clinical and Experimental Ophthalmology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00417-023-06071-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00417-023-06071-8\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00417-023-06071-8.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,19]],"date-time":"2023-10-19T05:06:12Z","timestamp":1697691972000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00417-023-06071-8"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,6,9]]},"references-count":29,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2023,11]]}},"alternative-id":["6071"],"URL":"https:\/\/doi.org\/10.1007\/s00417-023-06071-8","relation":{},"ISSN":["0721-832X","1435-702X"],"issn-type":[{"value":"0721-832X","type":"print"},{"value":"1435-702X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,6,9]]},"assertion":[{"value":"11 January 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"30 March 2023","order":2,"name":"revised","label":"Revised","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"11 April 2023","order":3,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"9 June 2023","order":4,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The TENAYA and LUCERNE trials were conducted in accordance with the International Council for Harmonisation E6 Guideline for Good Clinical Practice; tenets of the Declaration of Helsinki; applicable US Food and Drug Administration regulations and the European Union Clinical Trials Directive (2001\/20\/EC); and relevant local, state, and federal laws. Study protocols were approved by institutional review boards and ethics committees as applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Written informed consent was obtained from all patients in the TENAYA and LUCERNE trials.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"Not applicable.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to publish"}},{"value":"KT has received rewards from Bayer, Chugai Pharmaceutical Co., Ltd, Kyowa Kirin, Novartis Pharma, Santen, and Senju. CMGC is a consultant for Allergan, Bayer, Boehringer Ingelheim, Novartis, Roche, Samsung, and Topcon. TI is a consultant for Bayer, Boehringer Ingelheim, Chugai Pharmaceutical Co., Ltd\/Roche, Novartis, and Senju. TYYL receives research support from Bayer, Novartis, and Roche and is a consultant for Alcon, Allergan, Bayer, Boehringer Ingelheim, Novartis, Oculis, and Roche. MO receives speaking fees from Chugai Pharmaceutical Co., Ltd. YY receives financial support from Alcon Japan, Sanbio, and Santen Pharmaceuticals and speaking fees from Chugai Pharmaceutical Co., Ltd. MK, SO, and TS are employees of Chugai Pharmaceutical Co., Ltd. AK and VP are employees of Roche Products Ltd. HL is an employee of Genentech, Inc. BS is an employee of F. Hoffman-La Roche Ltd. WKL is a consultant for Bayer, Novartis, and Roche.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}]}}