Enrollment has been completed in a series of phase III studies investigating voclosporin (Lumeniq, Lux Biosciences) as a steroid-sparing agent for the treatment of noninfectious uveitis, according to Quan Dong Nguyen, MD, assistant professor of ophthalmology, Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore.

Voclosporin, formerly known as LX211, is a next-generation calcineurin inhibitor that, based on its evaluation in other indications, appears to have a better safety profile compared with other calcineurin inhibitors, including cyclosporine A and tacrolimus. In addition, results from evaluation of voclosporin in experimental models of autoimmune uveitis showed its use was associated with preservation of retinal structure and function.

Three pivotal studies are being conducted as part of the LUMINATE (Lux Uveitis Multicenter Investigation of a New Approach to TrEatment) clinical trial program. One is investigating the treatment of active intermediate, anterior and intermediate, posterior or panuveitis; a second is evaluating voclosporin for maintaining control of inflammation in patients with quiescent intermediate, anterior and intermediate, posterior or panuveitis; and the third enrolled patients with active anterior segment uveitis.

The studies are being conducted in centers across the United States, Canada, India, and Europe and include about 550 patients total. Each study has a dose-ranging design with three voclosporin treatment groups and a placebo control group. All studies include corticosteroid tapering to 0.5 mg/day of prednisone, and the maintenance study protocol involves withdrawal of concomitant immunomodulatory therapy.

"These trials are important because they represent the first prospective, placebo-controlled, masked clinical trials designed to seek an indication for a steroid-sparing drug specifically intended for uveitis," Dr. Nguyen said. "In addition, the data collected should provide us information on the natural history of uveitis and patient quality of life.

"The future of uveitis therapy seems bright, but for now, we still need to adhere to a therapeutic goal of accepting no tolerance for any degree of inflammation," he concluded.