Oral uveitis agent set for phase III trial

July 18, 2012
Ophthalmology Times Staff Reports

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

Jersey City, NJ-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.

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