Xbrane Biopharma has announced results from the six months interim read-out in the Phase III equivalence trial with the Lucentis biosimilar candidate Xlucane.
Xlucane met the primary endpoint demonstrating equivalent efficacy in change of BCVA (Best Corrected Visual Acuity) at week 8 of treatment compared to Lucentis, states the company in a press release. Xbrane confirms the plans to submit the Marketing Authorization Application (MAA) to European Medicines Agency (EMA) in Q3 2021 and the Biologics License Application (BLA) to US Food and Drug Administration (FDA) in Q4 2021 on the basis of the results.
“I want to extend a big thank you to all clinics and patients having participated in Xplore for making this possible despite the ongoing COVID-19 pandemic. We are now on track towards filing of Xlucane in Europe and the US during second half of 2021,” says Xbrane CEO Martin Åmark
A biosimilar candidate to Lucentis
Xlucane is a biosimilar candidate to Lucentis, a VEGF-a inhibitor used in treatment of serious eye diseases, mainly wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). Xplore is a randomized, double-blinded, multi-center study evaluating efficacy, safety, pharmacokinetics, and immunogenicity of Xlucane compared to Lucentis in patients with wAMD. The primary endpoint in the study is the change in BCVA (Best Corrected Visual Acuity) at week 8. wAMD patients were randomized (1:1) to receive monthly injections of Xlucane or the reference product, Lucentis, for a duration of one year. Approximately 140 clinics in 15 countries contributed to a recruitment completion of the 583 patients in November 2020. An interim read-out was performed when the last patient had reached month 6 in the treatment schedule.
Photo of Martin Åmark: Xbrane