Efficacy and Safety of the Biosimilar Ranibizumab FYB201 in Comparison to Lucentis in Patients With Neovascular Age-related Macular Degeneration

Summary

The purpose of this study is to determine the efficacy and safety of the biosimilar ranibizumab FYB201 in comparison to Lucentis in patients with neovascular age-related macular degeneration.

Timeline

Start

2015-12-19

Primary completion

2017-12

Completion

2018-06-06

Outcome

Met primary endpoint

release “the primary endpoint has been achieved in the COLUMBUS-AMD phase III trial” formycon.com ↗

release “primary endpoint has been achieved in the COLUMBUS-AMD trial, thus confirming comparable efficacy between FYB201 and the reference medicinal product Lucentis®” formycon.com ↗

release “Following the achievement of the primary endpoint of the COLUMBUS-AMD phase III study” formycon.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ranibizumab	Monoclonal antibody	—	Intravitreal

Indications