Isotechnika Inc. has announced that their partner, Lux Biosciences, Inc., reported the results from the three Phase 3 LUMINATE trials investigating voclosporin oral capsule (LUVENIQ or LX211) for the treatment of uveitis.
Voclosporin is a next generation calcineurin inhibitor that Isotechnika has licensed to Lux for ophthalmic indications. The data show a positive effect on ocular inflammation and a safety profile consistent with the expected use in uveitis. Following full analysis of the data, the results of the LUMINATE clinical trials will be submitted for publication and presented at upcoming conferences. In parallel, Lux Biosciences will be preparing submissions for approval. "The available results from the LUMINATE program demonstrate that LUVENIQ, if approved, can play a significant role in the treatment of inflammation in certain forms of sight-threatening uveitis," said Eddy Anglade, M.D., Lux Biosciences' Chief Medical Officer. "A significant unmet therapeutic need exists for an approved agent which is not a corticosteroid and allows sparing of those drugs to reduce their associated, serious side effects." "These results further demonstrate the ability of voclosporin to impact a wide range of autoimmune conditions and highlight its broad commercial potential," said Dr. Robert Foster, President and Chief Executive Officer of Isotechnika. "We are committed to support Lux as they move forward with their LUVENIQ filings." The three randomized, double-masked, dose-ranging and placebo-controlled trials comprising the LUMINATE Program, the largest clinical program ever conducted in uveitis, enrolled 558 patients in 7 countries (United States, Canada, United Kingdom, France, Germany, Austria and India). The key results in the LUMINATE trials were: