Lux completes enrollment for phase 3 uveitis study

Lux Biosciences has completed patient enrollment for a phase 3 clinical trial of a next-generation calcineurin inhibitor for treatment of non-infectious uveitis, according to a press release from Lux partner Isotechnika Pharma.

The randomized, double-masked, controlled study will evaluate the safety and efficacy of Luveniq (oral voclosporin) for non-infectious uveitis involving the intermediate or posterior segment of the eye. The trial will evaluate 155 patients over a 6-month period at 56 sites across North America, Europe and Brazil, the release said.

The trial’s results are expected to address the U.S. Food and Drug Administration’s request for additional clinical information in its August 2010 complete response letter to the new drug application, according to the release. If the results are positive, they may also support a resubmission of the application under priority review early next year and a regulatory filing to the European Medicines Agency.

Lux has exclusive worldwide rights to develop and market voclosporin for ophthalmic diseases. Isotechnika, which discovered the compound, will receive development milestone payments and royalties on net sales, according to the release.