Encouraging Results of SAR 1118 Dry Eye Disease Study

Introduction

In a Phase 2 dry eye trial, subjects receiving SAR 1118 demonstrated a reduction in corneal staining, increased tear production, and improved visual-related function as compared to placebo. These data were part of the scientific program of the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting held in Fort Lauderdale, Florida. SAR 1118 is a first-in-class topically administered small molecule integrin antagonist that inhibits T-cell mediated inflammation, a key component of dry eye disease.

Main Item

In the randomized, placebo-controlled, multi-center trial, which included 230 subjects with dry eye disease, SAR 1118 demonstrated dose-dependent significant improvements (p<0.05) in inferior corneal staining over 12 weeks.

As early as two weeks, a statistically significant(p<0.05) increase in tear production and improvement in visual-related functions (ability to read, drive at night, use a computer, and watch television) were observed, demonstrating early onset of action.

Visual-related function was assessed using the Ocular Surface Disease Index (OSDI), a validated instrument designed to measure the severity of dry eye disease and the impact on vision-related function and quality of life. SAR 1118 was safe and well-tolerated with no serious ocular adverse events reported. Most ocular adverse events were transient and related to initial instillation.

"We are encouraged by the clinical effects of SAR 1118 in improving both signs and symptoms of dry eye, which supports the broad anti-inflammatory mechanism of this novel molecule," commented Charles Semba, MD, Chief Medical Officer of SARcode Corporation. "We are excited to begin Phase 3 development in the later part of 2011, and have discussed appropriate and acceptable endpoints with the regulatory bodies to facilitate a smooth path towards approval."

"It is well known that dry eye disease can have a deleterious effect on visual function, daily activities, workplace productivity, and quality of life. The potential to impact a patient's quality of life in as early as 2 weeks could be a major advance in the current dry eye treatment model," said Quinton Oswald, Chief Executive Officer of SARcode Corporation. "We hope to achieve similar results in our Phase 3 program."

About SAR 1118

SAR 1118 is a potent novel small molecule lymphocyte function-associated antigen-1 (LFA-1; CD11a/CD18; alphaLbeta2) antagonist under investigation for a broad range of ocular inflammatory conditions including dry eye 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 central to a number of inflammatory stimuli. SAR 1118 has demonstrated potency in blocking LFA-1 binding to its cognate ligand, inter-cellular adhesion molecule-1 (ICAM-1; CD54), thereby inhibiting cell adhesion, cytokine production, and cellular proliferation in in vitro models.

Attribution/Source(s):

This peer reviewed publication was selected for publishing by the editors of Disabled World due to its significant relevance to the disability community. Originally authored by SARcode Corporation, and published on 2011/05/04 (Edit Update: 2023/04/01), the content may have been edited for style, clarity, or brevity. For further details or clarifications, SARcode Corporation can be contacted at . NOTE: Disabled World does not provide any warranties or endorsements related to this article.

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Cite This Page (APA): SARcode Corporation. (2011, May 4 - Last revised: 2023, April 1). Encouraging Results of SAR 1118 Dry Eye Disease Study. Disabled World. Retrieved December 12, 2024 from www.disabled-world.com/medical/clinical-trials/sar-1118.php

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