JERSEY CITY, NJ (October 26, 2009): An experimental drug, LX211 (LUVENIQ; oral voclosporin), may become the first approved oral treatment capable of modifying the course of uveitis, a group of serious eye conditions inevitably associated with either severe vision loss or substantial morbidity from steroid use. Results of international Phase 2/3 clinical trials conducted by Lux Biosciences, to be the subject of two podium presentations at the American Association of Ophthalmology (AAO) meeting and of a presentation at the satellite meeting of the American Uveitis Society (AUS) in San Francisco, October 24-27, highlight the ability of LX211 to control the inflammation that characterizes this potentially blinding eye disease and significantly reduce its rate of recurrence. Lux Biosciences plans to file an NDA and MAA for marketing approvals around year-end 2009 and early 2010 in the United States and Europe, respectively.
"The LX211-02 study was a double-masked, placebo-controlled, dose-ranging study that included 232 patients at 57 centers in North America, Europe and India with clinically inactive uveitis involving any location within the eye," said Bahram Bodaghi, M.D., Ph.D., Piti Salptrire Hospital Paris, France, who will present the study results on Monday October 26 at 8:50 am PT. "Results of this trial showed that LX211 was able to reduce recurrence of inflammation by 50% over placebo at the 0.4 mg/kg twice daily dose (p<0.05) and may therefore effectively increase the interval between inflammatory relapses to 24 months compared to 10 months with placebo."
"Given that inflammatory exacerbation is a direct trigger of vision loss," Prof. Bodaghi commented, "this result for LX211 is impressive. In addition to a marked reduction in recurrence of inflammation, visual acuity was preserved in this study. Moreover, these results suggest the potential for disease modification whereby treatment with LX211 alters the course of the disease leading u
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