Efficacy and Safety of Olopatadine/Mometasone Nasal Spray in Treating Seasonal Allergic Rhinitis in Pediatric Patients

Significant improvements in all individual nasal symptoms with GSP301 vs placebo.

Significant improvements in all individual nasal symptoms with Ryaltris vs placebo (secondary efficacy).

1. Gross, et al. Ann Allergy Asthma Immunol. 2019;122(6):630-638; data on file.     GSP301 is a combination of olopatadine hydrochloride and mometasone furoate. LS, least squares; rTNSS, reflective Total Nasal Symptom Score; SAR, seasonal allergic rhinitis.     Data on file – GSP301-305 Clinical Study Report.

Ryaltris provides improved nasal symptom relief vs monocomponents

Significant and clinically meaningful improvements in rTNSS.

Significant improvements in all individual nasal symptoms with Ryaltris vs placebo (secondary efficacy).
• Ryaltris vs placebo (days 1-14)
• Olopatadine vs placebo (days 1-10)
• Mometasone vs placebo (days 1-14)

GSP301 is a combination of olopatadine hydrochloride and mometasone furoate.     LS: Least squares     NS: Nasal spray     rTNSS: reflective Total Nasal Symptom Score     SAR: seasonal allergic rhinitis.     1. Gross, et al. Ann Allergy Asthma Immunol. 2019;122(6):630-638; data on file.

Onset of Action¹

A rapid onset of action (based on mean change from baseline in iTNSS from 15 minutes to 4 hours) was observed with Ryaltris vs placebo.

aSecondary efficacy     GSP301 is a combination of olopatadine hydrochloride and mometasone furoate.     CI: confidence interval     iTNSS: instantaneous Total Nasal Symptom Score     LS: least squares     SAR: seasonal allergic rhinitis.     1. Hampel FC, et al. Allergy Asthma Proc. 2019;40:261-272; data on file.

Clinically meaningful improvements in average 24-hour AM rTNSS and iTNSS over 52 weeks with Ryaltris vs placebo pH 3.7.

Clinically meaningful improvements in average 24-hour AM rTNSS and iTNSS over 52 weeks with Ryaltris vs placebo pH 3.7.

iTNSS: instantaneous Total Nasal Symptom Score     LS: least squares      PAR: perennial allergic rhinitis     rTNSS: reflective Total Nasal Symptom Score     aSecondary endpoint. GSP301 is a combination of olopatadine hydrochloride and mometasone furoate.     1. Segall, et al. Allergy Asthma Proc. 2019;40:301-310; data on file.

Significant and clinically meaningful improvements in rTOSS with Ryaltris vs placebo on each of the 14 study days.
Significant improvements in all individual ocular symptoms with Ryaltris vs placebo

aSecondary efficacy. GSP301 is a combination of olopatadine hydrochloride and mometasone furoate.     CI: confidence interval     LS: least squares     rTOSS: reflective Total Ocular Symptom Score     SAR: seasonal allergic rhinitis.     1. Hampel FC, et al. Allergy Asthma Proc. 2019;40:261-272; data on file.

Ryaltris significantly improved below mentioned seven individual domain scores compared with placebo:

Ryaltris improved overall RQLQ scores vs placebo from baseline to day 15.

1. Adapted from Hampel et al.2019.     MCID: minimum clinically important difference.     RQLQ: rhinoconjunctivitis quality of life questionnaire.