First oral uveitis drug reduces both inflammation and recurrence in potentially blinding e...(eart disease and diabetes. Mood disturba...)

"The tapering of systemic corticosteroids to 5 mg or less per day, as implemented successfully in the LUMINATE studies, provides for additional safety from steroid morbidities," Dr. Rosenbaum commented.

"We are pleased with the demonstrated clinical effect of LX211 (Luveniq) in uveitis, coupled with what appears to be an acceptable side effect profile while reducing the need for systemic corticosteroid to half of the current guideline recommendation," commented Ulrich Grau, Ph.D., Lux Biosciences' President and Chief Executive Officer. "We're now pursuing regulatory filings, and if approved for commercialization by the appropriate regulatory agencies, LX211 would become the first agent in this class available in the United States and most other markets for the treatment of uveitis."

For more information on uveitis, its incidence, and how the disease is currently treated, please see http://www.luxbio.com/Uveitis%20Backgrounder.pdf

The LUMINATE program consists of three protocols that included 218 patients with active non-infectious uveitis with posterior (behind the lens of the eye) manifestation of the disease (LX211-01); 232 patients with clinically quiescent disease (LX211-02); and 108 patients with active uveitis with anterior (front of the eye) manifestation of the disease (LX211-03). Data from these trials showed:

• Of the three doses studied, the 0.4 mg/kg BID dose had the most acceptable safety profile relative to effect on the disease. The adverse effects on the kidney (8.2% of subjects with decrease from baseline by ≥30% in glomerular filtration rate vs. 4.1 % in placebo) and blood pressure (mean increase in systolic BP by 6 mm Hg) will require monitoring, but were overall moderate and ma
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