Xbrane Biopharma AB (STO:XBRANE) has enrolled all of the planned 580 patients in XPLORE, the pivotal phase III trial for its biosimilar candidate Xlucane, the Swedish biopharmaceutical company reported on Wednesday.
Xlucane is a ranibizumab (Lucentis) biosimilar candidate, a so-called VEGFa-inhibitor, intended to be used to treat a number of serious eye diseases including wet age-related macular degeneration (AMD), diabetic macular edema (DME), diabetic retinopathy (DR) and retinal vein occlusion (RVO).
The objective of XPLORE is to demonstrate the equivalent efficacy and safety of Xlucane compared to Lucentis.
Top-line data from XPLORE is expected to be available in mid-2021, followed by filing of the Marketing Authorization Application (MAA) and Biologics License Application (BLA) to the European Medicines Agency (EMA) and US Food and Drug Administration (FDA), respectively.
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