Shire announced results from its Phase 3 OPUS-2 study and Phase 3 SONATA safety study investigating lifitegrast (5.0% ophthalmic solution) in adults with dry eye disease. Lifitegrast, a small-molecule integrin antagonist, may work by reducing inflammation through inhibition of lymphocyte function-associated antigen 1 (LFA-1) and preventing its binding to intercellular adhesion molecule-1 (ICAM-1) that influences T-cell activation and cytokine (protein) release.
OPUS-2 was a multicenter, randomized, double-masked, placebo-controlled, parallel-arm study comparing lifitegrast to placebo administered twice-daily for 84 days in dry eye patients with a history of active artificial tear use within 30 days prior to screening (n=718). A 14-day open-label placebo screening run-in period preceded randomization. Patients randomized into the study were not allowed to use artificial tears or certain other medications during the study.
In the OPUS-2 study, lifitegrast met one of the co-primary endpoints for the patient-reported symptom of improvement in dry eye compared with placebo (P<0.0001), but did not meet the second co-primary endpoint of the sign of inferior corneal staining (P=0.6186).
SONATA was a multicenter, randomized, double-masked, placebo-controlled study evaluating the safety of 5.0% lifitegrast vs. placebo administered twice-daily for 360 days in dry eye patients (n=332). Patients were not allowed to use contact lenses, or any topical ophthalmic treatments (eg, artificial tears, steroid drops, antihistamine drops or mast cell stabilizer drops) between Visits 1 and 3 (Day 14). Following completion of Visit 3 assessments, patients were allowed to use daily disposable contact lenses only if needed, and/or artificial tears up to four times a day as needed and/or topical ophthalmic steroids (loteprednol only), antihistamines or mast cell stabilizers.
Analysis of the primary endpoints of ocular and non-ocular adverse events (AEs) showed that ocular AEs occurring in ≥5% of subjects included installation site irritation (15% vs. 4.5% for placebo), installation site reaction (13.2% vs. 1.8% for placebo), visual acuity reduced (11.4% vs. 6.3% for placebo), and dry eye (1.8% vs. 5.4% for placebo). The most commonly reported non-ocular AE associated with lifitegrast was altered sense of taste (16.4% vs. 1.8% for placebo).
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