Clinical Study to Compare Efficacy and Safety of AVT06 and EU-Eylea (ALVOEYE)

Summary

This is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with Eylea in subjects with neovascular (wet) AMD.

Timeline

Start

2022-06-28

Primary completion

2023-11-17

Completion

2024-09-23

Outcome

Met primary endpoint

paper were contained within the pre-specified equivalence margin of ETDRS BCVA letter score of [-3.5 to 3.5] PMID 40512025 ↗

release “The confirmatory clinical, safety and efficacy study for AVT06, biosimilar candidate to Eylea® (aflibercept) met its primary endpoint” alvotech.com ↗

Publications

• Agostini H, Baumane K, Balciuniene VJ, Ozols K, Soni R, Hamdi S, Cirillo S, Rai M, Otto H, Leutz S, Sattar A, Berti F. A randomized, double-masked parallel-group, multicenter clinical study evaluating the efficacy and safety of the biosimilar candidate AVT06 compared to the reference product aflibercept in participants with neovascular age-related macular degeneration. Expert Opin Biol Ther. 2025 Jul;25(7):773-787. doi: 10.1080/14712598.2025.2519531. Epub 2025 Jun 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AVT06	Unknown	2 mg	Intravitreal
Subject	Aflibercept	Protein / enzyme biologic	2 mg	Intravitreal

Indications