Verkazia®

Pooled analysis of SICCANOVE and SANSIKA, two double-masked randomized vehicle-controlled phase 3 trials of 0.1% cyclosporine A cationic emulsion dosed once daily for 6 months in adults (395 on drug, 339 on vehicle): treated patients were more likely to be composite corneal staining plus OSDI responders at month 6, odds ratio 1.66 (95% CI 1.11 to 2.50, P = 0.015), holding in severe dry eye (OR 1.80, 95% CI 1.04 to 3.19, P = 0.038) and in Sjogren's syndrome with severe dry eye (OR 3.37, 95% CI 1.20 to 11.19, P = 0.030) but not in the overall Sjogren's population (OR 1.77, 95% CI 0.89 to 3.66, P = 0.109). Conjunctival HLA-DR expression fell versus vehicle (P = 0.002). Note the mismatch with this label: those trials dosed once daily in adults with dry eye, not QID for vernal disease, and dry eye is not a US-approved indication for this product.