Aurinia Pharmaceuticals announced that the last patient study visit has occurred in the phase 2/3 AUDREY clinical study evaluating voclosporin ophthalmic solution (VOS) for the potential treatment of dry eye syndrome (DES).
“Despite the challenges posed by the ongoing viral pandemic, our clinical operations team at Aurinia has maintained executional excellence by completing the treatment phase of our major clinical trial assessing VOS in this common chronic autoimmune disorder, which affects more than 16 million people in the United States,” Peter Greenleaf, President and Chief Executive Officer of Aurinia, said in a company news release. “Based upon the striking efficacy results observed with VOS in our head-to-head exploratory study against 0.05% cyclosporine, we are excited to see the results of this clinical trial which aims to fulfill a number of regulatory requirements typically required by the FDA for this indication.”
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 (STT) at 4 weeks. Secondary outcome measures include STT at 12 weeks and 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, 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 1 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 2 weeks, according to Aurinia Pharmaceuticals. Additionally, voclosporin was given at four times the dose of cyclosporine with no additional drop discomfort as measured by the drop discomfort scores at 1 and 5 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 randomized fashion.
Topline results from the AUDREY clinical study are expected to be reported during the fourth quarter of 2020.