Lux Biosciences has completed enrollment for the Luminate pivotal clinical trial program, which is investigating the use of Luveniq as a corticosteroid-sparing agent for the treatment of patients with non-infectious uveitis.
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As planned, the three randomized, placebo-controlled, double-masked studies together enrolled a total of about 560 patients at 58 sites in seven countries.
In the Luminate program Luveniq is being examined utilizing inflammation as an endpoint in both the anterior (front) and posterior (back) segments of the eye. If approved, Luveniq will be the first steroid-sparing agent to be commercialized for uveitis in the US and in most international markets.
Ulrich Grau, president and CEO of Lux, said: “As patients in the Luminate program are treated and followed for six months, we expect to complete these studies prior to year-end. If the studies are successful in demonstrating efficacy and safety, we will seek regulatory approval for Luveniq in 2009.”
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