Patient enrollment complete for Phase III Dry Eye Study of SAR 1118 (SARcode) - 07-Mar-2012

Patient enrollment has been completed for the first pivotal Phase III clinical study (OPUS-1) of SAR 1118, from SARcode, for Dry Eye Disease. OPUS-1 is a randomized, double-masked study evaluating the safety and efficacy of SAR 1118 5.0% ophthalmic solution compared to placebo over a 12 week period. A total of 588 patients with Dry Eye Disease have been enrolled at 13 clinical sites across the US. The primary endpoints in this study will assess both a sign and a symptom of Dry Eye Disease, and include corneal fluorescein staining score and vision-related function score (reading, driving at night, computer use, watching television) as measured by the Ocular Surface Disease Index (OSDI; a validated instrument designed to assess the impact of dry eye upon vision-related activities). Additionally, SARcode Bioscience announced that the United States Adopted Name (USAN) Council and the World Health Organization's International Nonproprietary Names (INN) program have adopted "lifitegrast" as the nonproprietary name for SAR 1118. Lifitegrast is an integrin antagonist specifically developed for topical ophthalmic use and targets a key cellular step that initiates a perpetual cycle of inflammation recognized to be central to the most common forms of dry eye disease.