{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,23]],"date-time":"2026-04-23T07:45:01Z","timestamp":1776930301925,"version":"3.51.2"},"reference-count":13,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"10","license":[{"start":{"date-parts":[[2024,9,12]],"date-time":"2024-09-12T00:00:00Z","timestamp":1726099200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Hexal AG (a Sandoz company), Holzkirchen, Germany"}],"content-domain":{"domain":["lww.com","ovid.com"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2024,10]]},"abstract":"<jats:sec>\n            <jats:title>Purpose:<\/jats:title>\n            <jats:p>The Phase 3 Mylight study was designed to confirm clinical equivalence of proposed biosimilar aflibercept (SOK583A1; Sandoz [proposed biosimilar aflibercept, SDZ-AFL]) to its reference biologic (Eylea; Regeneron Pharmaceuticals, Inc; Bayer AG [reference aflibercept, Ref-AFL]).<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Method:<\/jats:title>\n            <jats:p>Mylight was a prospective, double-masked, 2-arm, parallel Phase 3 study. Participants with neovascular age-related macular degeneration were randomized 1:1 to receive eight injections of SDZ-AFL (n = 244) or Ref-AFL (n = 240) over 48 weeks. The primary endpoint was mean change in best-corrected visual acuity score from baseline to Week 8. Secondary endpoints included anatomical outcomes, best-corrected visual acuity at Weeks 24 and 52, safety, and pharmacokinetics.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results:<\/jats:title>\n            <jats:p>Similarity in mean change in best-corrected visual acuity score was established between SDZ-AFL (n = 235) and Ref-AFL (n = 226) at Week 8 (difference: \u22120.3 [90% CI, \u22121.5 to 1.0]) and Week 52. No clinically meaningful differences occurred between groups in anatomical outcomes. Safety profiles were similar, with comparable incidences of treatment-related adverse events (SDZ-AFL: 2.5%; Ref-AFL: 2.9%). The incidence of anti-drug antibodies was similar between groups. Systemic free aflibercept concentrations 24 hours postdose were low and comparable between SDZ-AFL and Ref-AFL.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusion:<\/jats:title>\n            <jats:p>Proposed biosimilar aflibercept matched reference aflibercept in efficacy, safety, and pharmacokinetics in participants with neovascular age-related macular degeneration. Therefore, this Phase 3 study confirmed biosimilarity of SDZ-AFL to Ref-AFL.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1097\/iae.0000000000004174","type":"journal-article","created":{"date-parts":[[2024,6,5]],"date-time":"2024-06-05T21:00:10Z","timestamp":1717621210000},"page":"1704-1713","update-policy":"https:\/\/doi.org\/10.1097\/lww.0000000000001000","source":"Crossref","is-referenced-by-count":13,"title":["EFFICACY AND SAFETY OF THE PROPOSED BIOSIMILAR AFLIBERCEPT, SDZ-AFL, IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION"],"prefix":"10.1097","volume":"44","author":[{"given":"Arnaldo F.","family":"Bordon","sequence":"first","affiliation":[{"name":"Hospital Oftalmol\u00f3gico de Sorocaba, S\u00e3o Paulo, Brazil;"}]},{"given":"Peter K.","family":"Kaiser","sequence":"additional","affiliation":[{"name":"Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio;"}]},{"given":"Armin","family":"Wolf","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology, University Hospital Ulm, Ulm, Germany;"}]},{"given":"Liyi","family":"Cen","sequence":"additional","affiliation":[{"name":"Sandoz Inc, Princeton, New Jersey;"}]},{"given":"Jens","family":"Heyn","sequence":"additional","affiliation":[{"name":"Hexal AG, Holzkirchen, Germany;"}]},{"given":"Dragan","family":"Urosevic","sequence":"additional","affiliation":[{"name":"Sandoz AG, Basel, Switzerland;"}]},{"given":"Francis","family":"Dodeller","sequence":"additional","affiliation":[{"name":"Hexal AG, Holzkirchen, Germany;"}]},{"given":"Lisa","family":"Allmannsberger","sequence":"additional","affiliation":[{"name":"Hexal AG, Holzkirchen, Germany;"}]},{"given":"Rufino","family":"Silva","sequence":"additional","affiliation":[{"name":"Faculty of Medicine, University of Coimbra, Coimbra, Portugal;"},{"name":"Coimbra Medical Space, Coimbra, Portugal;"},{"name":"ULS de Coimbra, Coimbra, Portugal; and"},{"name":"Clinical Academic Centre of Coimbra, Coimbra, Portugal."}]}],"member":"276","published-online":{"date-parts":[[2024,9,12]]},"reference":[{"key":"R1-20250605","first-page":"e29583","article-title":"Age-related macular degeneration: epidemiology, pathophysiology, diagnosis, and treatment","volume":"14","author":"Vyawahare","year":"2022","journal-title":"Cureus"},{"key":"R2-20250605","doi-asserted-by":"crossref","first-page":"10594","DOI":"10.3390\/ijms221910594","article-title":"Ocular therapeutics and molecular delivery strategies for neovascular age-related macular degeneration (nAMD)","volume":"22","author":"Sarkar","year":"2021","journal-title":"Int J Mol Sci"},{"key":"R3-20250605","doi-asserted-by":"crossref","first-page":"2222545","DOI":"10.1080\/07853890.2023.2222545","article-title":"Incidence and prevalence of neovascular age-related macular degeneration: 15-year epidemiological study in a population-based cohort in Finland","volume":"55","author":"Korva-Gurung","year":"2023","journal-title":"Ann 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degeneration","volume":"108","author":"Brody","year":"2001","journal-title":"Ophthalmology"},{"key":"R7-20250605","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1038\/s41433-018-0300-3","article-title":"Action on neovascular age-related macular degeneration (nAMD): recommendations for management and service provision in the UK hospital eye service","volume":"33","author":"Gale","year":"2019","journal-title":"Eye (Lond)"},{"key":"R8-20250605","doi-asserted-by":"crossref","first-page":"1629","DOI":"10.3390\/biom12111629","article-title":"Current and novel therapeutic approaches for treatment of neovascular age-related macular degeneration","volume":"12","author":"ElSheikh","year":"2022","journal-title":"Biomolecules"},{"key":"R12-20250605","first-page":"1260","article-title":"Clinical and economic burden of neovascular age-related macular degeneration by disease status: a US claims-based analysis","volume":"27","author":"Almony","year":"2021","journal-title":"J Manag Care Spec 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