Aurinia Pharmaceuticals has started dosing patients in a Phase II/III clinical trial of voclosporin ophthalmic solution (VOS) for the treatment of dry eye syndrome (DES).
Voclosporin is an investigational calcineurin inhibitor. It acts as an immunosuppressant and blocks IL-2 expression and T-cell mediated immune responses.
Named AUDREY, the randomised, double-masked, vehicle-controlled, dose-ranging Phase II/III trial will assess the safety and efficacy of the medication in around 480 patients.
Participants will be administered with a 0.2%, 0.1% or 0.05% dose or vehicle twice daily for 12 weeks.
The trial’s primary outcome is the proportion of patients with a 10mm improvement in Schirmer Tear Test (STT) at four weeks.
Secondary outcome measures include STT at additional time points, fluorescein corneal staining (FCS) at various time points, change in eye dryness, burning/stinging, itching, and other safety endpoints.
Top-line data from the trial is expected in the second half of next year.
Aurinia Pharmaceuticals president and CEO Peter Greenleaf said: “Based upon the impressive results seen with VOS in the head-to-head exploratory Phase IIa study against cyclosporin A, we are focused on rapidly advancing this promising treatment for those who suffer from dry eye syndrome.
“Through the Phase II/III AUDREY trial, we will generate important dose-ranging and clinical data aimed at bringing VOS towards registration and commercialisation.”
The company reported data from the Phase II trial in January.
During the study, voclosporin demonstrated statistical superiority to 0.05% cyclosporin A on all objective endpoints, including FCS and STT, following two weeks of twice daily dosing.
The data showed no statistically significant or clinically meaningful difference in drop discomfort between the treatment groups.