Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray (Ryaltris)

Key Messages

• Canada’s Drug Agency (CDA-AMC) recommends that Ryaltris should not be reimbursed by public drug plans for the symptomatic treatment of moderate to severe seasonal allergic rhinitis and associated ocular symptoms in adults, adolescents, and children aged 6 years and older.
• Evidence from 3 clinical trials (2 in adolescent and adult patients with seasonal allergic rhinitis and 1 in children with seasonal allergic rhinitis) demonstrated that Ryaltris improved nasal and eye symptoms in people with seasonal allergic rhinitis compared to placebo. However, compared to mometasone nasal spray, the improvements were not clinically meaningful in adolescents and adults, and there was no comparative evidence available in children.
• The indirect evidence evaluated the comparative efficacy of Ryaltris versus intranasal corticosteroids and oral antihistamines in adolescent and adult patients, and versus intranasal corticosteroids in children. There were limitations in the indirect evidence that precluded meaningful conclusions on the efficacy of Ryaltris relative to active comparators in adolescent and adult patients or in children with seasonal allergic rhinitis.
• Patients identified a need for new treatments that control the symptoms of seasonal allergic rhinitis and improve their quality of life. However, based on the evidence reviewed during the initial meeting and the reconsideration meeting, the Canadian Drug Expert Committee (CDEC) could not determine whether Ryaltris would address the unmet needs of patients because of the uncertainty around the benefit of Ryaltris versus appropriate active comparators.