Biotechnology
Company Overview of Lux Biosciences, Inc.
Company Overview
Lux Biosciences, Inc., a biotechnology company, engages in the development and commercialization of medications for ophthalmic diseases in the United States and internationally. Its products comprise LUVENIQ, an oral form of calcineurin inhibitor voclosporin, which is used for the treatment of non-infectious uveitis; LX214, a topical formulation that contains mixed nanomicelles of voclosporin for ophthalmic use; LX212, a bioerodible polymer implant containing voclosporin; and LX213, a bioerodible/isotechnika implant. The company was incorporated in 2005 and is based in Jersey City, New Jersey.
3 Second Street
Harborside Financial Center Plaza 10
14th Floor
Jersey City, NJ 07302
United States
Founded in 2005
Key Executives for Lux Biosciences, Inc.
Lux Biosciences, Inc. Key Developments
Isotechnika Pharma Inc. announced that Lux Biosciences, Inc. has completed patient enrollment in its Phase 3 clinical study using voclosporin (branded as Luveniq(TM) by Lux) for the treatment of non-infectious uveitis, a cause of vision loss and long-term disability. Lux 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 anticipates that the results from this trial, if positive, will address the U.S. Food and Drug Administration's 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 additionally expects the trial results, if positive, to support a regulatory filing to the European Medicines Agency for Luveniq. The product has received Orphan Drug designation in both Europe and the United States for the treatment of non-infectious uveitis.
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