Next-generation calcineurin inhibitor in pivotal trials for noninfectious uveitis

November 8, 2008

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.

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

Voclosporin, formerly known as LX211, is a next-generationcalcineurin inhibitor that, based on its evaluation in otherindications, appears to have a better safety profile comparedwith other calcineurin inhibitors, including cyclosporine A andtacrolimus. In addition, results from evaluation of voclosporinin experimental models of autoimmune uveitis showed its use wasassociated with preservation of retinal structure andfunction.

Three pivotal studies are being conducted as part of the LUMINATE(Lux Uveitis Multicenter Investigation of a New Approach toTrEatment) clinical trial program. One is investigating thetreatment of active intermediate, anterior and intermediate,posterior or panuveitis; a second is evaluating voclosporin formaintaining control of inflammation in patients with quiescentintermediate, anterior and intermediate, posterior or panuveitis;and the third enrolled patients with active anterior segmentuveitis.

The studies are being conducted in centers across the UnitedStates, Canada, India, and Europe and include about 550 patientstotal. Each study has a dose-ranging design with threevoclosporin treatment groups and a placebo control group. Allstudies include corticosteroid tapering to 0.5 mg/day ofprednisone, and the maintenance study protocol involveswithdrawal of concomitant immunomodulatory therapy.

"These trials are important because they represent the firstprospective, placebo-controlled, masked clinical trials designedto seek an indication for a steroid-sparing drug specificallyintended for uveitis," Dr. Nguyen said. "In addition, the datacollected should provide us information on the natural history ofuveitis and patient quality of life.

"The future of uveitis therapy seems bright, but for now, westill need to adhere to a therapeutic goal of accepting notolerance for any degree of inflammation," he concluded.

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