Isotechnika Pharma Inc. (TSX: ISA) announced today that Lux Biosciences, Inc. (Lux) has commenced its pivotal Phase 3 trial using voclosporin for the treatment of non-infectious uveitis, a leading cause of vision loss and long-term disability.
The study is a 6-month randomized trial of voclosporin versus placebo in patients with active non-infectious intermediate, posterior, or pan-uveitis. This Phase 3 trial will involve 150 patients in North America and Europe. Lux is conducting this additional Phase 3 trial as outlined in the Complete Response Letter received in August, 2010, from the United States Food and Drug Administration (FDA).
“We are pleased with Lux’s continuing commitment to move voclosporin forward in non-infectious uveitis,” stated Dr. Robert Foster, President & CEO of Isotechnika Pharma.
In 2006, Isotechnika granted Lux worldwide rights to develop and commercialize voclosporin for ophthalmic diseases. In return, Isotechnika will receive development milestones payments, as well as royalties on net sales. Voclosporin (branded as Luveniq™ by Lux) was accepted for review by the European Medicines Agency (EMA) in March 2010. The product has received Orphan Drug designation in both Europe and the US for the treatment of non-infectious uveitis.
Source: ISOTECHNIKA PHARMA INC.