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First oral uveitis drug reduces both inflammation and recurrence in potentially blinding eye disease
Date:5/4/2009

nageable. Triglycerides and cholesterol were not elevated and had no negative impact on the cardiovascular safety profile. Hair growth (hirsutism) was observed in 5% of patients. Otherwise the safety profile was similar to placebo.

  • In study LX211-01 the 0.4 mg/kg BID dose fully met the primary endpoint of superiority to placebo at both weeks 16 (p=0.008) and week 24 (p=0.027) for mean change from baseline in vitreous haze, a validated measure of inflammation of the posterior segment of the eye. The magnitude of the effect was >1 step change from baseline, demonstrating a clinically relevant benefit.

  • In study LX211-02 the 0.4 mg/kg BID dose showed a reduction by 50% vs. placebo in rate of recurrence of inflammation at 6 months using a pre-specified analysis that accounted for data censoring due to non-efficacy-related discontinuations. This reduction was statistically significant (p=0.045), thus confirming the positive results from LX211-01.

  • In study LX211-03, treated patients reduced the cellular response in the front of the eye from an average of more than 25 white blood cells per high power microscopic field to an average of 6 to 10 cells per high power field. However, placebo-treated patients also improved in this study and it was therefore not possible to show that LX211 was effective for this rare subset of uveitis patients, those with refractory disease in the anterior portion of the eye.

    The LUMINATE program was conducted under the sponsorship of Lux Biosciences.


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