The Dry Eye Zone

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Drug news: SAR1118 Phase 2 results

SARcode Corporation Announces Phase 2 Study Results of SAR 1118 Topical Ophthalmic Solution for the Treatment of Dry Eye
PRNewswire, 5/3/2010

Study Shows Improvements in Both Signs and Symptoms of Disease
SAN FRANCISCO, May 3 /PRNewswire/ -- SARcode Corporation, a privately-held biotechnology company focused on developing a novel class of lymphocyte function-associated antigen-1 (LFA-1) antagonists, today announced results of a 230 patient Phase 2 proof-of-concept study evaluating topical SAR 1118 ophthalmic solution in the treatment of aqueous deficient dry eye (keratoconjunctivitis sicca). The study results were presented at the Dry Eye Summit meeting on April 30th in Fort Lauderdale, Florida, immediately prior to ARVO 2010, the annual meeting of the Association for Research in Vision and Ophthalmology. The study results demonstrated clear improvements in both signs and symptoms of dry eye at 12 weeks. SAR 1118 was well-tolerated, with no serious ocular adverse events reported.

"We are very pleased with the results of the Phase 2 study," said Charles Semba, MD, chief medical officer of SARcode. "We met our goals of showing improvements in both corneal staining and patient symptoms. We were encouraged too that SAR 1118 achieved these results within 12 weeks, suggesting that it might provide more rapid relief than currently available therapies."

About the Phase 2 Study

The study was a randomized, multicenter, double-masked study comparing SAR 1118 (0.1, 1.0, 5.0%) to placebo. A total of 230 subjects were randomized 1:1:1:1 to receive drops twice daily for 12 weeks. The primary objective measure was inferior corneal staining. The major secondary measures were Ocular Surface Disease Index (OSDI) symptom score and tear production by Schirmer tear test (STT)....

About SAR 1118

SAR 1118 is a potent novel small molecule lymphocyte function-associated antigen-1 (LFA-1; CD11a/CD18; alpha L beta 2) antagonist that can be targeted against a broad range of ocular inflammatory conditions including dry eye, uveitis, and diabetic macular edema. LFA-1 is member of the integrin family of adhesion receptors found on the surface of all leukocytes and represents a therapeutic target of the immune system central to a number of inflammatory stimuli, whether mediated by cytokines, prostaglandins, leukotrienes or complement. SAR 1118 has demonstrated significant potency in in vitro models in inhibiting cell adhesion, cytokine production, and cellular proliferation.
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