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, photophobia, eye pain and foreign body sensation at multiple time points, and additional safety endpoints. Initial analysis of these secondary outcomes suggests dose-dependent activity and safety were observed across dose groups compared to vehicle. Aurinia intends to conduct further analysis of the AUDREY dataset over the coming weeks.
About voclosporin ophthalmic solution (VOS)
VOS is an aqueous, preservative free nanomicellar solution containing 0.2% voclosporin. Voclosporin is an immunosuppressant, with a synergistic and dual mechanism of action. By inhibiting calcineurin, voclosporin blocks IL-2 expression and T-cell mediated immune responses.
About Dry Eye Syndrome (DES)
Dry eye syndrome (DES) is a chronic disease and is characterized by irritation and inflammation that occurs when the eye’s tear film is compromised by reduced tear production, imbalanced tear composition, or excessive tear evaporation. The impact of DES ranges from subtle, yet constant eye irritation to significant inflammation and scarring of the eye’s surface. Discomfort and pain resulting from DES can reduce quality of life and cause difficulty reading, driving, using computers and performing daily activities.