Aurinia Announces Topline Data from Phase 2/3 AUDREY Trial: Voclosporin Ophthalmic Solution (VOS) Fails to Meet Endpoints in Dry Eye Syndrome

Aurinia Announces Topline Data from Phase 23 AUDREY Trial Voclosporin Ophthalmic Solution (VOS) Fails to Meet Endpoints in Dry Eye Syndrome

Aurinia Pharmaceuticals announced topline data from the Phase 2/3 AUDREY trial evaluating voclosporin ophthalmic solution (VOS) for the potential treatment of dry eye syndrome (DES). The trial did not achieve statistical significance on its primary endpoint of a 10mm or greater improvement in STT at four weeks between active dose groups of VOS compared to vehicle. Based on these results, Aurinia is suspending the development program for VOS.

AUDREY was a randomized, double-masked, placebo-controlled, dose-ranging study evaluating the efficacy and safety of VOS in subjects with DES. A total of 508 subjects were enrolled. The study consisted of four arms with patients randomized 1:1:1:1 to either 0.2% VOS, 0.1% VOS, 0.05% VOS or placebo, dosed twice daily for 12 weeks. The primary outcome measure for the trial was the proportion of subjects with a 10mm or greater improvement in STT at four weeks. The percentage of patients achieving this endpoint was 11%, 9%, 10% and 5%, respectively.

Secondary outcome measures evaluated in the trial included STT at other time points, Fluorescein Corneal Staining (FCS) at multiple time points, change in eye dryness, burning/stinging, itching, ...

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