BRISBANE, Calif., Oct. 23, 2012 /PRNewswire/ -- SARcode Bioscience, Inc., announced topline 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.
"We are pleased that lifitegrast demonstrated impressive results in corneal staining parameters, since this has been historically challenging in the development of new therapies for patients with dry eye disease," commented Charles Semba, MD, Chief Medical Officer of SARcode Bioscience. "It is especially encouraging that common symptoms of dry eye disease were also reduced, providing evidence that improvement of the ocular surface may ameliorate symptoms of the disease."
SARcode Bioscience recently commenced a year-long safety study (SONATA) and will soon begin a second pivotal Phase 3 confirmatory study (OPUS-2). Both studies will support a planned New Drug Application filing.
"Dry eye is a debilitating disease affecting 25 million patients in the US, and contributes to significant social and economic costs," said Quinton Oswald, Chief Executive Officer of SARcode Bioscience. "Our team has spent several years developing this novel molecule specifically for dry eye disease. We are very pleased to continue advancing the program so patients suffering from this disease may have additional therapeutic options in the future."
Data from the OPUS-1 study will be presented during the Late Breaker Session at the upcoming American Academy of Ophthalmology Meeting in Chicago on Monday, November 12, 2012 by John D. Sheppard, MD, an investigator in the study.
Lifitegrast is an investigational novel small-molecule integrin antagonist that was "purpose-built" to meet several specifications that would make it an ideal dry eye therapy candidate. It was chosen from over one thousand synthesized molecules for its ability to specifically and potently block the lymphocyte function-associated antigen-1/intercellular adhesion molecule (LFA-1/ICAM-1) interaction, a validated target in the chronic dry eye inflammatory cycle which is central to T-cell activation, proliferation, migration, and inflammatory cytokine release at sites of ocular surface stress. Lifitegrast was engineered to provide good penetration into target periocular tissues, but low absorption into the systemic circulation, allowing for local delivery without adverse side effects. The molecule is also highly soluble in water, permitting easy formulation into an ophthalmic solution. In a randomized, placebo-controlled Phase 2 study of 230 subjects with dry eye disease conducted in 2010, lifitegrast ophthalmic solution demonstrated dose-dependent improvements in both signs and symptoms of dry eye and was well tolerated with no serious adverse events reported.
About the OPUS-1 Study
OPUS-1 is a prospective, randomized, double-masked, Phase 3 study that evaluated the efficacy and safety of lifitegrast ophthalmic solution, 5.0%, compared to placebo for the treatment of signs and symptoms of dry eye disease. The study included 588 subjects with dry eye disease from 13 sites in the US. Subjects received lifitegrast or placebo dosed two times a day for 12 weeks.
About Dry Eye Disease
Dry eye disease is a prevalent and often chronic condition estimated to affect approximately 25 million people in the US and 370 million people worldwide. This number is expected to grow substantially in the next decade due to an aging population and increasing incidence of type-2 diabetes, both of which contribute to higher rates of this condition. Dry eye disease is among the most common disorders treated by ophthalmologists throughout the world, and has been shown to have a significant impact upon quality-of-life. Dry eye varies in severity and etiology, and symptoms most commonly manifest as ocular discomfort, eye dryness, and tear film instability due to decreased quality or quantity of tears. A major contributing factor towards the development of dry eye is inflammation caused by T-cell infiltration, proliferation and inflammatory cytokine production that can lead to reduction in tear film quality and ocular surface damage.
About SARcode Bioscience
SARcode Bioscience, Inc., founded in 2006, is a privately held biopharmaceutical company based in Brisbane, CA. SARcode Bioscience's lead development program is a novel class of lymphocyte function-associated antigen-1 (LFA-1) antagonists for the treatment of T-cell mediated inflammatory diseases. Institutional investors include Alta Partners, Clarus Venture Partners, Rho Ventures and Sofinnova Ventures. For more information: www.sarcode.com.
SOURCE SARcode Bioscience, Inc.