Isotechnika Pharma Inc IPHAF

Voclosporin and uveitis

[narcissist]

There is not much news available on uveitus other than the fact that the application remains viable. LUX is still recruiting patients for a stage 3 clinical trial (study identifier NCT01243983). The ClinicalTrial.gov web site - a service of the US National Institutes of Health - indicates that the LUX study is designed to study the "Efficacy and Safety of Voclosporin to Treat Active Noninfectious Uveitis." The chief contact for the study is LUX Biosciences Medical Officer Eddy Anglade, MD. The primary objective of this study is to assess the safety and efficacy of voclosporin as therapy in subjects with active noninfectious uveitis involving the intermediate and/or posterior ocular segments. The secondary objective of this study is to assess the relationship of voclosporin exposure to efficacy and safety parameters and there are 150 (estimated) partients enrolled. The estimated study completion date is May, 2012.  As far as I can ascertain the study is active - or will be active - at 36 sites, all in the United States. LUX still has a prominent recruitment link on its website for this study. LUX withdrew its marketing application from the European CHMP in October because of a negative letter from CHMP. That notification turned really on the insufficient data available on which to base a risk/benefit approval of the LUX indication. The risk is specifically hypertension, which is a known side effect of this class of drug. LUX has subsequentluy stated that they remain "fully committed to developing a new treatment alternative for patients with uveitis, the fourth leading cause of blindness in developed countries." The company has stated it intends to reapply based upon the results of the current trials.