Lux Biosciences has announced that the Pediatric Committee of the European Medicines Agency (EMEA) has issued a positive opinion on Lux's Pediatric Investigation Plan (PIP) for Luveni (oral formulation of voclosporin), the company's potential first-in-class product in Phase 3 development for sight-threatening non-infectious uveitis. The PIP covers children and young adults between the ages of 2 and 17 years who are affected with uveitis. An accepted PIP is a pre-requisite for European approval of new drugs according to legislation passed in January 2007. The aim of the legislation is to facilitate the development of new medicines for children without subjecting them to unnecessary clinical trials or delaying the authorization of those medicines for use in adults.
"Uveitis is a chronic inflammatory disease of the eye that affects relatively few children compared to adults," commented Ulrich Grau, Ph.D., Lux Biosciences' President and CEO. "However, children face an even greater risk of blindness from uveitis than do adults, as the rate and spectrum of sight-threatening complications are significant and persist over time. Physicians today rely on corticosteroids to help control uveitis, but the chronic use of corticosteroids at the doses required to hold the disease in check is burdened with serious side effects, such as bone loss, metabolic disturbances, weight gain, depression and many others. Thus, the need for new steroid-sparing therapies for this disease is as critical for children as it is for adults."
Lux Biosciences completed patient enrollment in mid-2008 in its Luminate (Luveniq Uveitis Multicenter Investigation of a New Approach to TrEatment) pivotal clinical trial programme, which is investigating the use of Luveniq in adult patients with non-infectious uveitis. Data from the Luminate program, which consists of three randomized, placebo-controlled, double-masked studies that together enrolled a total of about 560 patients at 58 sites in 7 countries, are expected in Q1 2009. Pending a positive outcome of the Luminate Phase 3 trials and subsequent approval by U.S. and European regulatory agencies, Luveniq will provide the first steroid-sparing therapy for uveitis.