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SARcode Announces Phase 2 Study Results of SAR 1118 Topical Ophthalmic Solution for the Treatment of Dry Eye


5/3/2010 9:57:36 AM

SARcode Corporation Announces Phase 2 Study Results of SAR 1118 Topical Ophthalmic Solution for the Treatment of Dry Eye

Study Shows Improvements in Both Signs and Symptoms of Disease

PR Newswire

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 Dry Eye

Dry eye (keratoconjunctivitis sicca) is a multifactorial disease of the tears and the ocular surface that results in symptoms of discomfort, visual disturbance and tear film instability with the potential to damage the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface (Dry Eye Work Shop (DEWS, 2007)). According to the DEWS report, approximately 5 million patients, 50 years and older, have moderate to severe dry eye. A major contributing factor towards the development of dry eye is T-cell infiltration, proliferation and inflammatory cytokine production in diseased ocular tissues that leads to reduction in tear film quality and ocular surface inflammation. LFA-1 regulates T-cell adhesion, migration, proliferation, and cytokine production and represents a target for therapeutic intervention.

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.

About SARcode Corporation

SARcode is a venture-backed biopharmaceutical company focused on the development of best in class small molecule LFA-1 antagonists as novel nonsteroidal immunomodulators/anti-inflammatory agents for the treatment of T-cell mediated inflammatory diseases. Institutional investors include Alta Partners and Clarus Venture Partners.

For contact information, visit www.sarcode.com

SOURCE SARcode Corporation



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