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Enrollment completed for phase 3 dry eye study

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BRISBANE, Calif. — The last patient has been enrolled in the phase 3 study of SAR 1118 ophthalmic solution for treatment of dry eye, SARcode Bioscience announced in a press release.

The company also announced the nonproprietary name lifitegrast has been adopted for SAR 1118 by the United States Adopted Name Council and the World Health Organization's International Nonproprietary Names program.

SAR 1118 is a small-molecule integrin antagonist that inhibits T-cell inflammation by blocking and binding two surface proteins associated with dry eye, the release said.

The OPUS-1 phase 3 trial is a double-masked, randomized examination of SAR 1118 5% ophthalmic solution, according to the release. The study will involve 588 patients across 13 clinical sites in the U.S., comparing safety and efficacy against placebo over a 12-week period.

Primary endpoints will assess sign and symptom of dry eye and will include corneal fluorescein staining score and vision-related function score, the release said.