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Aurinia Completes Final Patient Treatment in AUDREY Phase 2/3 Clinical Trial of Voclosporin Ophthalmic Solution for Dry Eye Syndrome
- Voclosporin ophthalmic solution (VOS) results on track to be reported in the fourth quarter of 2020 - - Study builds on positive head-to-head data with
About this update from Aurinia Pharmaceuticals Inc
[{"type":"text","content":"\n- Voclosporin ophthalmic solution (VOS) results on track to be reported in the fourth quarter of 2020 -\n\n- Study builds on positive head-to-head data with approved treatment reported in prior Phase 2a study -\n\n- Dry eye syndrome is a chronic autoimmune disorder affecting quality of life for millions in the U.S. -\n\n VICTORIA, British Columbia--(BUSINESS WIRE)--\nAurinia Pharmaceuticals Inc. (NASDAQ: AUPH / TSX:AUP) (Aurinia or the Company), a late-stage clinical biopharmaceutical company focused on advancing voclosporin across multiple autoimmune conditions, today 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).\n\n“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,” said Peter Greenleaf, President and Chief Executive Officer of Aurinia. “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.”\n\nThe 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 four 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 additio...