Pooled data from studies of Ryaltris shows improvements in allergic rhinitis symptoms.- Glenmark Pharma

Glenmark Pharmaceuticals announced results from new analyses of pooled data from clinical studies of Ryaltris (olopatadine hydrochloride and mometasone furoate monohydrate nasal spray), an investigational fixed-dose combination nasal spray for the treatment of seasonal allergic rhinitis (SAR) in patients 12 years of age and older. In a pooled analysis of efficacy and safety from three SAR clinical trials involving more than 2,900 patients, treatment with Ryaltris demonstrated significant and clinically meaningful improvements in average morning and evening reflective Total Nasal Symptoms Scores (rTNSS) and instantaneous TNSS versus placebo. Similarly, Ryaltris provided significant and clinically meaningful improvements in rTNSS and iTNSS versus the monotherapy active controls (olopatadine, respectively; mometasone,respectively). Rates of treatment emergent adverse events (TEAEs) were consistent between Ryaltris (13.9%), olopatadine (13.2%), mometasone (7.9%) and placebo (9.5%).

Another pooled analysis of data from the same clinical study population demonstrated a rapid, 15-minute onset of action with Ryaltris. Additionally, the onset of action with Ryaltris treatment was maintained over the duration of the assessment (four hours), in comparison to placebo. Additionally, Ryaltris treatment resulted in statistically significant improvements in ocular symptoms versus placebo on day one through day 14.

The third pooled analysis of data from this clinical study population showed that treatment with Ryaltris led to statistically significant improvements in overall quality of life, compared to placebo, as demonstrated by the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Activities [RQLQ(S)]. Ryaltris treatment also provided statistically significant improvements versus placebo in each individual domain of RQLQ(S): activities; emotional; eye symptoms; nasal symptoms; non-nose/eye symptoms; practical problems; and sleep. Data were presented at the 2019 Annual Meeting of the American Academy of Allergy, Asthma and Immunology.

Comment: Glenmark Pharmaceuticals has studied Ryaltris in seven clinical trials involving more than 4,000 patients. Results from these clinical trials of Ryaltris have been previously presented at key medical meetings.