28 September 2020 - - The last patient study visit has occurred in the Phase 2/3 AUDREY clinical study evaluating voclosporin ophthalmic solution for the potential treatment of dry eye syndrome, Canada-based biopharmaceutical company Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (TSX: AUP) said.


The AUDREY Phase 2/3 DES study is evaluating VOS via a randomized, double-masked, vehicle-controlled, dose ranging study evaluating efficacy and safety in subjects with DES compared to formulation. A total of 509 subjects were enrolled.

The study consists of four arms with a 1: 1: 1: 1 randomization schedule, 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 study is the proportion of subjects with a 10mm improvement in Schirmer's Tear Test at four weeks.

Secondary outcome measures include STT at 12 weeks and other time points, Fluorescein Corneal Staining at multiple time points, change in eye dryness, burning/stinging, itching, photophobia, eye pain and foreign body sensation at multiple time points, change in Symptom Assessment in Dry Eye (SANDE) score at multiple time points, and additional safety endpoints.

In January of 2019, Aurinia reported that although VOS (voclosporin 0.2%) administered twice daily did not meet the primary endpoint of drop discomfort at one-minute, it was superior to Restasis (0.05% cyclosporine A) administered twice daily in all objective endpoints including FCS and STT.

This statistical superiority was seen as quickly as two weeks. Additionally, voclosporin was given at four times the dose of cyclosporine with no additional drop discomfort as measured by the drop discomfort scores at one and five minutes after application.

Based on these data the company has gained confidence that VOS represents a potential best-in-class calcineurin inhibitor in ophthalmic indications.

This head-to-head study against the market leader was the first study that has ever shown treatment superiority vs. an active comparator in a double-blind randomised fashion.

Top-line results from the AUDREY clinical study are expected to be reported during the fourth quarter of 2020.

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 that has been shown to have a more predictable pharmacokinetic and pharmacodynamic relationship, increase in potency (versus cyclosporine) 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 clinically and statistically superior to 0.05% cyclosporine A (Restasis) administered twice daily across all objective endpoints over four weeks.

Dry eye syndrome 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.

DES is a chronic disease estimated to affect more than 16 m people in the United States.

There are multiple FDA approved therapies for the treatment of dry eye; however, there is opportunity for potential improvements in the effectiveness, tolerability and onset of action.

Aurinia Pharmaceuticals is a late-stage clinical biopharmaceutical company focused on developing and commercializing therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need.

The company is currently seeking FDA approval of voclosporin for the potential treatment of lupus nephritis and evaluating voclosporin ophthalmic solution in a Phase 2/3 study for the treatment of dry eye syndrome.

The company's head office is in Victoria, British Columbia, its US commercial hub in Rockville, Maryland, and focuses its development efforts globally.