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SARcode Bioscience reports phase 3 dry eye study results
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A novel small-molecule integrin antagonist significantly improved ocular discomfort, dryness and corneal staining scores in a phase 3 study, according to a news release.
The prospective, randomized, double-masked OPUS-1 study included 588 participants with dry eye disease at 13 centers in the United States who were administered lifitegrast ophthalmic solution 5% (SARcode Bioscience) or placebo twice daily for 12 weeks.
Inferior corneal staining, total corneal staining, mean ocular discomfort and mean eye dryness scores improved significantly from baseline to week 12 in the lifitegrast group vs. the control group (P = .0007, P = .0148, P = .0273 and P = .0291, respectively).
“We are pleased that lifitegrast demonstrated impressive results in corneal staining parameters, since this has been historically challenging in the development of new therapies for patients with dry eye disease,” Charles Semba, MD, chief medical officer of SARcode Bioscience, said in the release.
Data from the OPUS-1 study will be presented Nov. 12 at the American Academy of Ophthalmology meeting in Chicago.
SARcode Bioscience has begun the SONATA yearlong safety study of lifitegrast, and the OPUS-2 phase 3 confirmatory study is scheduled to begin soon. Both studies are intended to support a New Drug Application filing, according to the release.