Comparing the Efficacy and Safety of Biosimilar Candidate Xlucane Versus Lucentis® in Patients With nAMD

Summary

The objectives of the study are to demonstrate the equivalence of Xlucane to Lucentis® in treatment of subjects with wet (ie, neovascular) age-related macular degeneration (wAMD).

Timeline

Start

2019-04-19

Primary completion

2021-05-11

Completion

2021-11-11

Outcome

Met primary endpoint

release “Xlucane™ met the primary endpoint demonstrating equivalent efficacy in change of BCVA (Best Corrected Visual Acuity) at week 8 of treatment compared to Lucentis®.” xbrane.com ↗

release “Xplore clinical equivalence study for Xlucane™, a biosimilar candidate for Lucentis®. By Xbrane’s assessment, Xlucane™ met the primary outcome measure” xbrane.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ranibizumab	Monoclonal antibody	0.05 ml	Intravitreal
Subject	Ranibizumab	Monoclonal antibody	10 mg/ml	Intravitreal

Indications