Aurinia says VOS demonstrates statistically superior efficacy versus Restasis
Aurinia Pharmaceuticals announced positive results for its exploratory Phase 2 head-to-head study evaluating the efficacy, safety and tolerability of voclosporin ophthalmic solution versus Restasis for the treatment of dry eye syndrome. Both drugs were shown to be well-tolerated and there was no statistical difference between VOS and Restasis for the primary endpoint as both drugs exhibited low drop discomfort scores. On the key pre-specified secondary endpoints of Schirmer Tear Test/STT, and Fluorescein Corneal Staining/FCS, which are FDA-accepted efficacy endpoints, VOS showed rapid and statistically significant improvements over Restasis at Week 4. This 100-patient, double-masked, head-to-head study was designed to evaluate the efficacy, safety and tolerability of VOS versus Restasis in subjects with DES. Both arms of the study received either VOS or Restasis administered twice daily, in both eyes, for 28 days. Key pre-specified secondary endpoints, which are FDA-accepted endpoints, include STT, FCS, and assessments of dry eye symptoms. Both treatment arms also demonstrated substantial and statistically significant improvements on the Symptom Assessment in Dry Eye score from baseline to Week 4. No serious adverse events were reported in the study, and there were no unexpected safety signals.