Voclosporin uveitis study fails to meet primary endpoint

Edmonton, Alberta-Isotechnika Pharma Inc. has announced that the phase III clinical study of voclosporin for the treatment of non-infectious uveitis did not meet its primary endpoint of change from baseline.

The clinical study, conducted by Lux Biosciences Inc. and under a license agreement with Isotechnika, found that voclosporin failed to meet its primary endpoint of change from baseline in vitreous haze at 12 weeks or at the time of treatment failure, if earlier. As a result, Lux Biosciences will not move forward with its submission for regulatory approval in the United States and Europe.

"These trial results are disappointing for patients suffering from non-infectious uveitis, for Lux Biosciences, and for Isotechnika," said Robert Foster, PhD, chief executive officer of Isotechnika. "However, they by no means spell the end of our core voclosporin development program."

Isotechnika has successfully developed voclosporin in the area of nephrology, which has long been Isotechnika's primary focus. The company also has confidence in the potential of voclosporin to address other unmet medical needs, such as kidney transplant rejection and lupus nephritis.

The company granted Lux Biosciences worldwide rights to develop and commercialize voclosporin for ophthalmic indications in the hope that the expansion of its platform into other medical specialties might help to maximize the drug's full medical and commercial potential.