AUPH - Aurinia suspends voclosporin program as Phase 2/3 study fails to achieve significant improvement in dry eye syndrome

Aurinia Pharmaceuticals (AUPH) down 10% after-hours after announcing topline data from the Phase 2/3 AUDREY clinical study 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 Schirmer Tear Test ((STT)) at four weeks between active dose groups of VOS compared to vehicle. A total of 508 subjects were enrolled. The study consisted of four arms with a 1:1:1:1 randomization schedule, in which patients received either 0.2% VOS, 0.1% VOS, 0.05% VOS or vehicle, dosed twice daily for 12 weeks.At VOS 0.2%, result was 11%; with Odds-Ratio of 2.48 vs. vehicle (95% CI, p=0.13).At VOS 0.1%, result was 9%; with Odds-Ratio of 1.78 (95% CI, p=0.28).At VOS 0.05%, result was 10%; with Odds-Ratio of 2.18 (95% CI, p=0.09).Aurinia is suspending the development program for VOS based upon these results. Secondary outcome measures evaluated

For further details see:

Aurinia suspends voclosporin program as Phase 2/3 study fails to achieve significant improvement in dry eye syndrome