Published on July 9, 2012 at 12:06 PM
Lux Biosciences, Inc. today announced the completion of patient enrollment in its Phase 3 clinical study of Luveniq™ (oral voclosporin) for the treatment of non-infectious uveitis. Lux Biosciences anticipates that data from the Phase 3 study will be available early in the first quarter of 2013.
The Phase 3 study is a six-month, randomized, multi-center, double-masked, controlled trial to evaluate the efficacy and safety of Luveniq for the treatment of non-infectious uveitis involving the intermediate or posterior segments of the eye. The study includes 155 patients and is taking place at 56 sites across North America, Europe and Brazil. The primary endpoint of the trial is the change from baseline in vitreous haze at 12 weeks or at the time of treatment failure, if earlier.
Lux Biosciences anticipates that the results from this trial, if positive, will address the U.S. Food and Drug Administration's (FDA) request for additional clinical information as part of the Complete Response letter regarding the New Drug Application (NDA) for Luveniq issued in August 2010, and 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 for Luveniq.
Dean Mitchell, President and Chief Executive Officer of Lux Biosciences, commented, "The design of the current trial will allow us to build on the insights gained from the previously successful trial, while enhancing the understanding of how physicians may best use Luveniq in their patient population. We are very pleased with the conduct of the trial and thank the investigators involved for their tireless efforts and support in advancing this innovative and important therapy."
Source Lux Biosciences, Inc.