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Auven Therapeutics completes enrollment in phase 3 study of Seciera for dry eye
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Auven Therapeutics completed enrollment in a phase 3 confirmatory study of Seciera for the treatment of dry eye disease, according to a press release.
Seciera (OTX-101) is a novel patented nanomicellar formulation of cyclosporine. The multicenter, randomized, double-masked, placebo-controlled, two-arm phase 3 trial enrolled 747 patients with dry eye disease at 47 investigational sites in the United States.
The primary efficacy endpoint of the trial is the percent of patients with 10 mm improvement in tear production, as measured by Schirmer’s test, compared with a placebo group. Secondary endpoints include a significant reduction in the signs of ocular surface inflammation, as measured by conjunctival and corneal staining, according to the release.
The company expects to release topline results by the end of the year.