The Phase 2/3 AUDREY clinical study evaluating Aurinia Pharmaceuticals’ (NASDAQ:AUPH; TSX:AUP) voclosporin ophthalmic solution (VOS) for the potential treatment of dry eye syndrome did not achieve statistical significance on its primary endpoint.
Aurinia is suspending the dry eye development program for VOS based on the study’s results.
“While surprised by these results, we remain focused on preparing voclosporin for lupus nephritis, which has a different formulation and delivery mechanism, compared with VOS,” Peter Greenleaf, president and CEO, said in a statement.
“As we approach our lupus nephritis PDUFA action date, the Aurinia team remains committed to our mission of developing novel treatments for people with debilitating and severe autoimmune disease,” he added.
The AUDREY trial enrolled 508 subjects and consisted of four arms. Patients received either 0.2% VOS, 0.1% VOS, 0.05% VOS or vehicle, dosed twice daily for 12 weeks. The primary outcome measure for the trial was the proportion of subjects with a 10 mm or greater improvement in the Schirmer tear test at four weeks.
Initial analysis of secondary outcomes suggests dose-dependent activity and safety were observed across dose groups, compared with vehicle. Further analysis of the AUDREY dataset will be conducted over the coming weeks.
