Isotechnika partner nears end of patient recruitment

Isotechnika Pharma (TSX:ISA) said its partner, Lux Biosciences, expects to complete patient recruitment of its continuing Phase 3 trial of Luveniq (voclosporin) in North America for the treatment of non-infectious uveitis in early 2012. Lux also has decided to modify its European regulatory strategy by withdrawing its application for marketing authorization of Luveniq for the [...]

Isotechnika partner starts uveitis Phase 3 trial

Isotechnika Pharma’s (TSX: ISA) partner Lux Biosciences has begun an additional Phase 3 trial using voclosporin for the treatment of non-infectious uveitis, a leading cause of vision loss and long-term disability. The six-month study will involve 150 patients in North America and Europe with active non-infectious intermediate, posterior, or pan-uveitis. Lux is conducting this additional [...]

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 [...]

FDA cancels meeting but review of Isotechnika’s voclosporin continues

The FDA has cancelled a June 28 dermatology and ophthalmology drugs advisory committee review of a new drug application by Isotechnika Pharma’s (TSX:ISA) partner Lux Biosciences for their voclosporin drug as a treatment of non-infectious uveitis. On its website, the FDA said the meeting was cancelled to allow time for the “resolution of several outstanding [...]

Isotechnika has a powerhouse franchise in voclosporin

Dr. Robert Foster still longs to make Isotechnika’s (TSX: ISA) lead drug, voclosporin, the standard of care in the field of preventing organ rejection in transplantation surgery. This may seem somewhat unusual, since voclosporin is currently being considered by regulators in North America and Europe to treat uveitis, a chronic inflammation of the eye that [...]

EMA accepts Isotechnika-Lux filing for eye drug

The European Medicines Agency has accepted a marketing application filed by Isotechnika Pharma’s (TSX:ISA) partner, Lux Biosciences, for voclosporin to treat non-infectious uveitis involving the posterior segment of the eye, the fourth leading cause of legal blindness in the industrialized world. “With the EMA acceptance of the dossier we now expect the review process to [...]

Isotechnika partner files drug applications

Isotechnika Pharma’s (TSX:ISA) partner, Lux Biosciences, has filed a new drug application with the FDA and a market authorization application with the European Medicines Agency for voclosporin, under the proposed brand name Luveniq. Voclosporin is a next generation calcineurin inhibitor to treat non-infectious uveitis, involving the posterior segment of the eye, a leading cause of [...]