Company Overview of SARcode Bioscience, Inc.

SARcode Bioscience, Inc. Presents at Leerink Swann Global Healthcare Conference, Feb-13-2013 11:30 AM. Venue: Waldorf Astoria Hotel, New York, New York, United States. Speakers: Quinton Oswald, Chief Executive Officer.

SARcode Bioscience, Inc. announced that the initial subject has been enrolled in a second pivotal Phase 3 clinical efficacy study (OPUS-2) of lifitegrast ophthalmic solution 5.0%. OPUS-2 will assess the efficacy and safety of lifitegrast in the treatment of dry eye disease. Approximately 700 subjects will be randomized to receive lifitegrast or placebo twice daily over 12 weeks. The co-primary endpoints of the study are inferior corneal fluorescein staining score and eye dryness. Lifitegrast has been studied in over 900 subjects to date and has demonstrated statistical significance in several signs and symptoms of dry eye disease. Dose-dependent improvements were observed in both corneal and conjunctival staining, key indicators of ocular surface health. Lifitegrast also improved eye dryness and ocular discomfort, the two most commonly reported symptoms of dry eye Lifitegrast was well tolerated and there were no unexpected or serious ocular adverse events. The most commonly reported ocular adverse events were irritation and pain upon initial instillation of lifitegrast, and were generally mild and transient in nature. The results from OPUS-1 and OPUS-2, along with results from an ongoing year-long safety study called SONATA, will support a planned New Drug Application.

SARcode Bioscience, Inc. announced top line results from OPUS-1, a pivotal Phase 3 study of lifitegrast ophthalmic solution, 5.0%, versus placebo for the treatment of dry eye disease. In the study, which included 588 subjects, lifitegrast demonstrated superiority over placebo in the improvement of inferior and total corneal staining scores from baseline to week 12 (P=0.0007 and P=0.0148, respectively). Ocular surface damage, which is a hallmark of chronic inflammation from dry eye disease, is often detected using these staining parameters. Lifitegrast also significantly improved the most commonly reported symptoms of dry eye disease in the study, which were ocular discomfort and eye dryness. The mean ocular discomfort score and mean eye dryness score were lower in the lifitegrast group than in the placebo group at week 12 (P=0.0273 and P=0.0291, respectively). Lifitegrast was well tolerated and there were no unexpected or serious ocular adverse events. The most commonly reported ocular adverse events were irritation and pain upon initial instillation of lifitegrast, and were generally mild and transient in nature.