Xbrane Biopharma has reported results from the 12-months data from the Phase III equivalence trial Xplore with the Lucentis biosimilar candidate Xlucane.
These data support the ongoing registration process for Xlucane, states the company. As previously announced, Xlucane met the primary endpoint demonstrating equivalent efficacy in the change of BCVA (Best Corrected Visual Acuity) at week 8 of treatment compared to Lucentis. Further, the full 12-months data, as per Xbrane’s assessment, reveals no clinically meaningful differences between Xlucane and Lucentis.
No clinically meaningful differences regarding efficacy, safety, pharmacokinetics, and immunogenicity between Xlucane and Lucentis
As communicated on June 27, 2021, based on an interim-read out, Xlucane met the primary endpoint in Xplore demonstrating equivalent efficacy measured in improvement in BCVA at week 8 compared to Lucentis. Equivalence was determined since the two-sided 95% confidence interval around the difference in change in BCVA at week 8 between Xlucane and Lucentis® was within the pre-defined equivalence margin as agreed with the EMA and FDA.
The last patient had their last visit in November 2021 and the full 12-months data from all patients in the study has now been compiled and analyzed. As per Xbrane’s assessment, the Xplore study reveals no clinically meaningful differences regarding efficacy, safety, pharmacokinetics, and immunogenicity between Xlucane and Lucentis.