-Patient  enrollment has been completed for a phase III clinical trial of oral  voclosporin (Luveniq, Lux Biosciences)  for the treatment of non-infectious uveitis.

Oral voclosporin will be evaluated in a 6-month, randomized,  multicenter, double-masked, controlled trial to evaluate its efficacy and  safety for the treatment of non-infectious uveitis involving the intermediate  or posterior segments of the eye. A total of 155 patients will be enrolled at  56 sites across North America, Europe, and Brazil. The primary endpoint of the  trial will be the change from baseline in vitreous haze at 12 weeks or at the  time of treatment failure, if earlier. 

Lux Biosciences anticipates data from the trial will be  available early in the first quarter of 2013. The company also anticipates that  the results from this trial, if positive, will address the FDA’s request for  additional clinical information as part of the complete response letter  regarding the New Drug Application (NDA) for oral voclosporin issued in August  2010, and that it also will support a resubmission of the NDA under priority  review early in 2013.

Lux Biosciences additionally expects the trial results, if  positive, to support a regulatory filing to the European Medicines Agency.

Patient enrollment has been completed for a phase III clinical trial of oral voclosporin (Luveniq, Lux Biosciences) for the treatment of non-infectious uveitis.