Phase 3 trials are underway for a biotechnology company’s drug to treat non-infectious Uveitis, an inflammatory eye disease and the fourth leading cause of blindness among the working age population in the United States. The move is intended to satisfy safety and efficacy issues raised in a complete response letter by the U.S. Food and Drug Administration two years ago.
Lux BioSciences has finished recruiting for the study for Luveniq that includes 155 patients taking place at 56 sites in North America, Brazil and Europe, according to a company statement. The Jersey City, New Jersey-based company expects to have data from the study in early 2013. The company is expecting the results of the trials to address similar concerns raised by the European Medicines Agency review of the drug.
Lux Biosciences is developing Lunveniq, the oral version of vaclosproin, in collaboration with Isotechnika Pharma.
There is no known cause of non-infectious Uveitis, although it is associated with genetics and autoimmune diseases.
At the time the company initially filed for approval in February 2010 it was granted priority review, a designation given to drugs providing major advances in treatment or providing a treatment where no adequate therapy exists.
Although its patient population is relatively small at 300,000, noninfectious Uveitis has an extreme impact, Dean Mitchell, Lux Biosciences CEO, told MedCity News. “It affects people much younger than other eye diseases like macular degeneration. People get it in their 40s, in their most productive years and it has a big socio-economic impact.”