March 30, 2009
Lux BioSciences released positive results from three phase III trials of LX211 for the treatment of uveitis. The three randomized, double-masked, dose-ranging and placebo-controlled trials comprised the LUMINATE Program and enrolled 558 subjects across several countries. The trials included LX211-01, which enrolled 218 subjects with active non-infectious uveitis with posterior manifestation of the disease, LX211-02 which enrolled 232 subjects with clinically inactive and LX211-03 which enrolled 108 subjects with active uveitis with anterior manifestation of the disease. Efficacy was measured at six months to assess the degree of inflammation, utilizing standardized scales for evaluation of inflammation in the anterior and posterior segments of the eye. In study LX211-01 a dose of 0.4 mg/kg twice daily fully met the primary endpoint of superiority to placebo at both weeks 16 (p≡0.008) and week 24 (p≡0.04) for mean change from baseline in vitreous haze, a measure of inflammation of the posterior segment of the eye. In study LX211-02 a dose of 0.4 mg/kg twice daily showed a reduction by 50% versus placebo in rate of recurrence of inflammation at six months (p≡0.046). In study LX211-03 the efficacy of the LX211 dose groups and placebo did not separate during the steroid taper; all showed an improvement by >1 step mean reduction from baseline in anterior chamber cells, a validated measure of inflammation in the anterior segment of the eye. LX211 was determined to be safe and well tolerated.