537:
Rapid Onset of Action on Nasal Symptoms and Ocular Symptom Improvement With Olopatadine/Mometasone Combination Nasal Spray in Patients With Seasonal Allergic Rhinitis
Sunday, March 4, 2018
South Hall A2 (Convention Center)
Gary Berman, MD, Niran J. Amar, MD, Craig F. LaForce, MD, Aurora Breazna, PhD, Cynthia F. Caracta, MD, Sudeesh K. Tantry, PhD
RATIONALE: In two randomized double-blind studies, twice-daily GSP301 nasal spray—a fixed-dose combination of olopatadine hydrochloride and mometasone furoate—significantly improved reflective total nasal symptom score (rTNSS) versus placebo (primary endpoint; presented elsewhere). GSP301 onset of action and reflective total ocular symptom scores (rTOSS) are presented here.

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.