METHODS: In each study (study 1 [NCT02631551]; study 2 [NCT02870205]), patients ≥12 years with seasonal allergic rhinitis (SAR) were equally randomized to GSP301 (olopatadine 665μg/mometasone 25μg BID), olopatadine (665μg BID), mometasone (25μg BID), or placebo for 14 days. GSP301 onset of action was assessed by mean change from baseline in average instantaneous TNSS (iTNSS) at various timepoints (from 15 minutes to 4 hours post-dose) versus placebo and analyzed via mixed-effect model repeated measures, adjusting for covariates.
RESULTS: A total of 1,180 and 1,176 patients were randomized in studies 1 and 2, respectively. A rapid onset of action for GSP301 was observed at 15 minutes post-dose versus placebo in study 1 (least squares mean difference [95% CI]: -0.35 [-0.63, -0.07]; P=0.014) and study 2 (-0.34 [-0.65, -0.04]; P=0.028), an effect that was maintained at each subsequent timepoint assessed. Additionally, GSP301 significantly improved rTOSS versus placebo in both studies (study 1: -0.49 [-0.79, -0.19], P=0.0014; study 2: -0.52 [-0.84, -0.20], P=0.001). Treatment-emergent adverse events were low and comparable across treatments.
CONCLUSIONS: In two SAR studies, GSP301 BID treatment had a rapid onset of action of 15 minutes, provided significant improvements in ocular symptoms versus placebo, and was well tolerated.