Lux Biosciences receives FDA clearance for uveitis drug

Jersey City, NJ-Now that the 30-day waiting period has ended for the investigational new drug application filed by Lux Biosciences Inc. for the development of LX211 in uveitis, the company will begin three controlled, double-masked clinical trials of the next-generation calcineurin inhibitor in early 2007. The studies collectively will enroll more than 500 patients in North America and Europe.

The first study will investigate the use of the drug as a steroid-sparing agent in the treatment of active posterior, intermediate, and panuveitis. The second trial will examine its ability to maintain control of inflammation in patients with quiescent posterior, intermediate, and panuveitis. The third study will investigate its use as a steroid-sparing agent in the treatment of patients with active anterior chamber inflammation. If the trials are successful, the company hopes to bring the drug to market in 2009.

Lux Biosciences has an exclusive worldwide license for ophthalmic indications related to LX211 from Isotechnika Inc., Edmonton, Canada. Clinical data gathered to date indicate that the agent prevents rejection in transplant patients and in a range of autoimmune diseases, including non-infectious uveitis. It appears to be well-tolerated. Lux Biosciences also plans to develop this molecule in other ophthalmic indications, such as dry eye syndrome.

“A well-studied and approved medication other than steroids would be enormously beneficial for patients who suffer from [uveitis],” said Ulrich Grau, PhD, president and chief executive officer of Lux Biosciences.