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

Abstract

The Phase 3 Mylight study was designed to confirm clinical equivalence of proposed biosimilar aflibercept (SOK583A1; Sandoz [SDZ-AFL]) to its reference biologic (Eylea®; Regeneron Pharmaceuticals, Inc.; Bayer AG [Ref-AFL]). Mylight was a prospective, double-masked, 2-arm, parallel phase 3 study. Participants with neovascular age-related macular degeneration (nAMD) 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 (BCVA) score from Baseline to Week 8. Secondary endpoints included anatomical outcomes, BCVA at Weeks 24 and 52, safety, and pharmacokinetics. Similarity in mean change in BCVA score was established between SDZ-AFL (n=235) and Ref-AFL (n=226) at Week 8 (difference: –0.3 [90% CI: –1.5, 1.0]), and to 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 post-dose were low, and comparable between SDZ-AFL and Ref-AFL. SDZ-AFL matched reference aflibercept in terms of efficacy, safety, and pharmacokinetics in participants with nAMD. Therefore, this Phase 3 study confirmed biosimilarity of SDZ-AFL to Ref-AFL.