Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH/TSX: AUP), a clinical stage biopharmaceutical company focused on the global immunology market, today announced the initiation of its Phase 2 trial evaluating voclosporin ophthalmic solution (VOS) for the treatment of dry eye syndrome (DES).
VOS, which is a proprietary nanomicellar formulation, enables high concentrations of voclosporin to be incorporated into a clear aqueous, preservative-free solution for local delivery to the ocular surface. This patented formulation has the potential to result in improved efficacy, dosing frequency, and tolerability versus the current treatments for DES.
This Phase 2 study is evaluating the ocular tolerability of VOS 0.2% versus Restasis® (cyclosporine ophthalmic emulsion 0.05%) at four weeks in subjects with mild to moderate DES. This robust head-to-head trial is recruiting 90 patients in sites across the United States, and the study is expected to complete at the end of 2018. Key secondary endpoints include Ocular Surface Disease Index (OSDI), System Assessment in Dry Eye (SANDE), Individual Symptom Severity Assessments and Drop Discomfort Visual Analog Scale (VAS) scores, Fluorescein Corneal Staining (FCS), and Schirmer Tear Test (STT).
"Topical calcineurin inhibition is thought to be a mainstay of treatment for dry eye, and based on its unique profile, we believe that VOS has the potential to compete in the multi-billion-dollar prescription dry eye market," said Richard M. Glickman, Aurinia's Chairman and Chief Executive Officer. "Our goal with this program is to develop a best-in-class treatment option, and upon completion, we will look to evaluate strategic alternatives for this asset."
VOS has demonstrated safety and tolerability in a human Phase Ib study (n=35), supporting its development for the treatment of DES. It has also previously shown evidence of efficacy in canine studies, which are being conducted by Merck Animal Health.