EFFICACY AND SAFETY OF THE PROPOSED BIOSIMILAR AFLIBERCEPT, SDZ-AFL, IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: 52-Week Results From the Phase 3 Mylight Study.

Autor:	Bordon AF; Hospital Oftalmológico de Sorocaba, São Paulo, Brazil., Kaiser PK; Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio., Wolf A; Department of Ophthalmology, University Hospital Ulm, Ulm, Germany., Cen L; Sandoz Inc, Princeton, New Jersey., Heyn J; Hexal AG, Holzkirchen, Germany., Urosevic D; Sandoz AG, Basel, Switzerland., Dodeller F; Hexal AG, Holzkirchen, Germany., Allmannsberger L; Hexal AG, Holzkirchen, Germany., Silva R; Faculty of Medicine, University of Coimbra, Coimbra, Portugal.; Coimbra Medical Space, Coimbra, Portugal.; ULS de Coimbra, Coimbra, Portugal; and.; Clinical Academic Centre of Coimbra, Coimbra, Portugal.
Jazyk:	angličtina
Zdroj:	Retina (Philadelphia, Pa.) [Retina] 2024 Oct 01; Vol. 44 (10), pp. 1704-1713. Date of Electronic Publication: 2024 Sep 12.
DOI:	10.1097/IAE.0000000000004174
Abstrakt:	Purpose: 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]). Method: 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. Results: 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: -0.3 [90% CI, -1.5 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. Conclusion: 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. (Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Opthalmic Communications Society, Inc.)
Databáze:	MEDLINE
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