Aurinia Pharmaceuticals announced it has completed enrollment for the phase 2/3 AUDREY clinical trial evaluating voclosporin ophthalmic solution (VOS) for the potential treatment of dry eye syndrome (DES).
“Voclosporin’s proven mechanism of action as a novel calcineurin inhibitor gives us confidence in its potential as a new option for combating the autoimmune processes underlying dry eye syndrome, which still negatively impacts quality of life for millions despite currently available therapies,” Peter Greenleaf, President and Chief Executive Officer of Aurinia, said in a company news release. “Given the extraordinary events of 2020, I would like to sincerely thank the patients, investigators, and the entire Aurinia team that has made this milestone achievable. Following the remaining 12-week treatment period and closing out of clinical trial activities, we look forward to reporting data from this trial in the fourth quarter of this year.”
The AUDREY trial is a randomized, double-masked, vehicle-controlled, dose-ranging study evaluating the efficacy and safety of VOS in subjects with DES. A total of 509 subjects were enrolled and randomized into one of four arms with a 1:1:1:1 randomization schedule, in which patients receive either VOS 0.2%, VOS 0.1%, VOS 0.05% or vehicle, dosed twice daily for 12 weeks. The primary outcome measure for the trial is the proportion of subjects with a 10mm or greater improvement in Schirmer Tear Test (STT) at 4 weeks. Secondary outcome measures will include 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. Topline results from the AUDREY clinical study are anticipated during the fourth quarter of 2020. AUDREY builds on positive exploratory phase 2 results demonstrating that 0.2% VOS administered twice daily was superior to cyclosporin A 0.05% (Restasis) administered twice daily across all objective endpoints.
Discomfort and pain resulting from DES can reduce quality of life and cause difficulty reading, driving, using computers and performing daily activities. There are multiple FDA approved therapies for the treatment of dry eye; however, there remains significant opportunity for potential improvements in the effectiveness, tolerability and onset of action.
About Voclosporin ophthalmic solution
Voclosporin ophthalmic solution (VOS) is an aqueous, preservative free nanomicellar solution intended for use in the treatment of DES. Voclosporin is a potentially best-in-class calcineurin inhibitor (CNI) that has been shown to have a more predictable pharmacokinetic and pharmacodynamic relationship, increase in potency (versus cyclosporin) and an improved metabolic profile compared to legacy CNIs. Calcineurin inhibition is a validated mechanism for the treatment of ocular surface diseases. Positive phase 2 results demonstrated that VOS 0.2% administered twice daily was superior to cyclosporin A 0.05% (Restasis) administered twice daily across all objective endpoints.