Lux-Isotechnika get complete response letter from FDA

Isotechnika Pharma’s (TSX:ISA) partner, Lux Biosciences, has received a complete response letter from the FDA about its new drug application for voclosporin in the treatment of non-infectious uveitis, involving the intermediate or posterior segments of the eye.

The FDA has requested additional information and recommended that an additional clinical trial be conducted in order to consider a future approval of voclosporin for this indication.

“I am delighted and encouraged that the board of directors and management of Lux are fully prepared to rapidly initiate recruitment of the additional clinical study required to complete the submission to the FDA,” Isotechnika CEO Dr. Robert Foster said in a statement.

A review by the European Medicines Agency of a marketing authorization application for voclosporin is scheduled for completion in the first quarter of 2011.