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Press Release 27 June 2021 22:40:00 CEST BIOPHARMA Xlucane ™ meets the primary endpoint in the pivotal Phase III trial with Xlucane ™ - regulatory submission in EU and US planned for second half of 2021 Xbrane Biopharma AB ( publ ) ( " Xbrane " or " the Company " ) ( Nasdaq Stockholm : XBRANE ) today announces top - line results from the 6 months interim read - out in the pivotal 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® . 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 interim results . Xbrane and its co - development partner STADA Arzneimittel AG ( " STADA " ) are committed to bring Xlucane ™ to market and contribute to an increased worldwide access to an effective and safe treatment option to millions of patients suffering from serious eye diseases . 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 XlucaneTM 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 successful recruitment completion of the 583 patients in November 2020 , this despite the challenges due to the COVID - 19 pandemic . An interim read - out was performed when the last patient had reached month 6 in the treatment schedule . 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 EMA and FDA . Furthermore , no clinically meaningful differences on secondary endpoints regarding pharmacokinetic , safety and immunogenicity between Xlucane ™ and Lucentis® could be observed . Xbrane will receive data on additional secondary endpoints and analyze these further , along with above mentioned endpoints , during this summer . The complete dataset is planned to be presented in a scientific journal or at a scientific conference during 2022 at the earliest . Xbrane Biopharma | Retzius väg 8 | SE - 171 65 Solna