JAN 02, 2013
Lux Biosciences Inc. will no longer seek regulatory approval of Luveniq (voclosporin) for non-infectious uveitis following poor phase 3 results.
Luveniq, a calcineurin inhibitor, failed to meet the study’s primary endpoint of improvement in vitreous haze. The randomized, double-masked, controlled trial evaluated 155 patients over a six-month period at 56 sites across North America, Europe and Brazil.
“These trial results are disappointing, for patients suffering from non-infectious uveitis, for Lux and for Isotechnika,” commented Dr. Robert Foster, CEO of Isotechnika.
Development of voclosporin in the area of nephrology has long been Isotechnika’s primary focus. The company had granted Lux worldwide rights to develop and commercialize voclosporin for ophthalmic indications.
Dr. Foster indicated in the press release that Isotechnika will continue to pursue its core development program for voclosporin with an emphasis on nephrology.