Voclosporin: newer analyses of a randomized, controlled trial for noninfectious uveitis

Abstract

AbstractPurpose To provide an overview of the voclosporin clinical development program for noninfectious uveitis involving the posterior segment.Methods Two trials, LX211‐01 (active uveitis) and LX211‐02 (clinically controlled, quiescent uveitis), were conducted for noninfectious uveitis involving the posterior segment. All trials were dose‐ranging and double‐masked. Study LX211‐01 enrolled 218 patients with active, posterior segment uveitis. The co‐primary efficacy endpoints were mean change from baseline in vitreous haze (VH) score after 16 and 24 weeks of therapy or at time of rescue, if earlier. Study LX211‐02 enrolled 232 patients with clinically quiescent posterior segment uveitis. The primary endpoint for this study was the proportion of patients who experienced an inflammatory exacerbation.Results In Study LX211‐01, the voclosporin 0.4 mg/kg group BID demonstrated statistically significant differences from placebo in the co‐primary endpoints, Week 16 and Week 24 (p=0.008 at 16 weeks, p=0.027 at 24 weeks). Analyses of important subpopulations, support the effect of voclosporin on severe uveitis. In Study LX211‐02, voclosporin 0.4 mg/kg BID reduced the rate of recurrence of inflammatory exacerbation in patients with quiescent disease by up to 50% over a 26‐week period.Conclusion In Study LX211‐01, clinically meaningful reduction in vitreous haze with strong statistical significance was observed. The response to treatment with voclosporin was early and sustained. In Study LX211‐02, there was an up to 50% reduction vs. control in inflammatory exacerbation recurrence rate. Voclosporin safety is consistent with the class and is manageable with routine monitoring. Commercial interest