Dry eye trial enrollment complete

Brisbane CA-SARcode Bioscience Inc. has completed patient enrollment in its first pivotal phase III clinical study (OPUS-1) of SAR 1118 ophthalmic solution for dry eye disease.

Also, the company announced that the solution has been given the nonproprietary name of lifitegrast via the Adopted Name Council and the World Health Organization’s International Nonproprietary Names program.

Lifitegrast is a first-in-class small-molecule integrin antagonist designed to inhibit T-cell inflammation by blocking the binding of two surface proteins (LFA-1 and ICAM-1) that mediate the chronic inflammatory cascade associated with dry eye disease. It was developed specifically for topical ophthalmic use.

OPUS-1 is a randomized, double-masked study evaluating the safety and efficacy of lifitegrast 5.0% ophthalmic solution compared with placebo over 12 weeks. A total of 588 patients with dry eye disease have been enrolled at 13 clinical sites across the United States.

The primary endpoints in this study will assess both a sign and a symptom of dry eye disease and will include corneal fluorescein staining score and vision-related function score (reading, driving at night, computer use, watching television) as measured by the Ocular Surface Disease Index.

“We look forward to the eventual analysis of the top-line data once OPUS-1 is completed,” said Charles Semba, MD, chief medical officer. Results should be announced mid-year, he added.

Quinton Oswald, the company’s chief executive officer, said, “We believe that lifitegrast will represent a significant advance in dry eye treatment, since it may address not only a clinical sign but also improve a patient’s ability to function in the face of this often debilitating condition.”

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