Regulatory Approval Details
Glenmark Specialty S.A. received U.S. FDA approval to expand the use of RYALTRIS® (olopatadine hydrochloride and mometasone furoate) Nasal Spray, 665 mcg/25 mcg per spray, for the treatment of symptoms of Seasonal Allergic Rhinitis (SAR) in pediatric patients aged 6 to less than 12 years.
Expanded Indication Coverage
With this approval, RYALTRIS® is now approved in the United States for adults and pediatric patients aged 6 years and older, extending this treatment option to a younger pediatric population.
Clinical Study Support
The approval was supported by a Phase 3, randomized, double-blind, placebo-controlled study involving 446 children aged 6 to 11 years with Seasonal Allergic Rhinitis. The study demonstrated that RYALTRIS® improved nasal symptoms compared with placebo and was well tolerated over the 14-day treatment period.
Market Context and Epidemiology
Seasonal allergies are common among school-age children in the United States. According to the U.S. Centers for Disease Control and Prevention, 25% of children aged 6 to 11 years had a diagnosed seasonal allergy in 2024. Seasonal Allergic Rhinitis affects far more than nasal symptoms, significantly impacting children's overall health, emotional well-being, sleep, and participation in physical activity.
Management Commentary
Marc Kikuchi, President & Business Head, North America, stated: "This approval marks an important step in expanding access to RYALTRIS® in the United States by extending its use to children aged 6 to less than 12 years with Seasonal Allergic Rhinitis. It also strengthens the role of RYALTRIS® as a key innovative brand within Glenmark's growing US respiratory portfolio." He added: "Our transition to direct commercialization gives us greater ownership of the brand and enables closer engagement with healthcare professionals and patients."
Commercialization Strategy
Effective April 1, 2026, Glenmark Pharmaceuticals Inc., USA assumed responsibility for the end-to-end commercialization and distribution of RYALTRIS® in the United States. Glenmark now directly leads the product's brand strategy, market access, distribution and customer engagement.
Product Background
RYALTRIS® is a fixed-dose combination nasal spray that combines olopatadine hydrochloride (an antihistamine) and mometasone furoate (a corticosteroid) in a single formulation. It was initially approved by the U.S. FDA in 2022 for the treatment of symptoms of Seasonal Allergic Rhinitis (SAR) in adults and pediatric patients 12 years of age and older.
Global Presence
RYALTRIS® has established a broad international footprint, with approvals across key markets including the European Union, United Kingdom, Australia, South Korea, Russia, and China. In FY26, RYALTRIS® was launched in 11 additional markets, further expanding its global presence to 56 countries.
Important Safety Information
CONTRAINDICATIONS: Patients with known hypersensitivity to any ingredients of RYALTRIS®, including mometasone furoate.
WARNINGS AND PRECAUTIONS: Epistaxis, nasal ulcerations, nasal septal perforations, impaired wound healing, and Candida albicans infection. Somnolence: Avoid engaging in hazardous occupations requiring complete mental alertness. Avoid concurrent use of alcohol or other CNS depressants. Glaucoma and cataracts monitoring required. Hypersensitivity reactions. Immunosuppression and Risk of Infections. Hypercorticism and adrenal suppression. Potential reduction in growth velocity in children.
ADVERSE REACTIONS: The most common adverse reactions (≥1% incidence) are dysgeusia, epistaxis, and nasal discomfort.
INDICATIONS: RYALTRIS® is indicated for the treatment of symptoms of seasonal allergic rhinitis in adult and pediatric patients of age 6 years and older.