Systemic voclosporin for uveitis treatment

To date cyclosporine is the only immunosuppressive drug approved for the treatment of uveitis in Germany. However, side effects often limit its use in daily practice. Voclosporin (LuveniqA (R)) represents a next generation calcineurin inhibitor which had shown efficacy in an animal model of experimental autoimmune uveitis as well as in clinical trials for the prevention of renal allograft rejection and for plaque psoriasis. The LUMINATE program included three prospective, randomized, double-masked, placebo-controlled multicenter trials which demonstrated the efficacy and tolerability of voclosporin 0.4 mg/kg b.i.d. in noninfectious intermediate and posterior uveitis and panuveitis. In Europe, the Marketing Approval Application (MAA) of voclosporin for the treatment of uveitis was submitted to the European Medicines Agency (EMA) in February 2010 and could be approved in March 2011.