A Study to Compare SB15 (Proposed Aflibercept Biosimilar) to Eylea in Subjects With Neovascular Age-related Macular Degeneration (AMD)

Phase 3 Completed 449 enrolled Samsung Bioepis Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, Pharmacokinetics (PK), and immunogenicity of SB15 compared to Eylea® in subjects with neovascular AMD.

Timeline

Start: 2020-06-23
Primary completion: 2021-04-15
Completion: 2022-03-16

Outcome

Met primary endpoint

paper 6.7 letters vs 6.6 letters, respectively; difference, 0.1 letters; 95% CI, -1.3 to 1.4). PMID 37289448 ↗

paper In this phase 3 randomized clinical trial, SB15 and AFL showed equivalent efficacy PMID 37289448 ↗

release “The primary endpoint was met, as LS mean (SE) change from baseline in BCVA at Week 8 was SB15” samsungbioepis.com ↗

release “The primary endpoint was met, as LS mean (SE) change from baseline in BCVA at Week 8 was SB15: 6.7” samsungbioepis.com ↗

Publications

Woo SJ, Bradvica M, Vajas A, Sagong M, Ernest J, Studnicka J, Veith M, Wylegala E, Patel S, Yun C, Orski M, Astakhov S, Toth-Molnar E, Csutak A, Enyedi L, Kim T, Oh I, Jang H, Sadda SR. Efficacy and Safety of the Aflibercept Biosimilar SB15 in Neovascular Age-Related Macular Degeneration: A Phase 3 Randomized Clinical Trial. JAMA Ophthalmol. 2023 Jul 1;141(7):668-676. doi: 10.1001/jamaophthalmol.2023.2260.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aflibercept	Protein / enzyme biologic	2 mg	Intravitreal
Subject	SB15	Unknown	2 mg	Intravitreal