FDA Expands Ryaltris Use in Children Aged 6 to 11 Years

Key Takeaways

• The expanded indication now includes pediatric patients aged 6 to younger than 12 years with seasonal allergic rhinitis.
• In a 446-patient phase 3 randomized, double-blind, placebo-controlled study, twice-daily dosing for 14 days was associated with greater nasal symptom improvement than placebo.
• Treatment was reported as well tolerated, and the labeling highlights corticosteroid-related growth monitoring alongside standard nasal and ocular or systemic warnings.

The FDA expanded Ryaltris use to children aged 6 to younger than 12 years with seasonal allergic rhinitis, extending the product's labeled population to a younger pediatric group. Ryaltris is a fixed-dose olopatadine hydrochloride and mometasone furoate nasal spray that was first approved in 2022 for seasonal allergic rhinitis in patients aged 12 years and older. The revised labeling lowers the starting age for this indication from 12 years to 6 years while keeping it limited to seasonal allergic rhinitis.

Support for the expansion came from a phase 3 pediatric trial in children aged 6 to 11 years with seasonal allergic rhinitis. Investigators randomized 446 participants in a double-blind, placebo-controlled study evaluating one spray in each nostril twice daily for 14 days. The trial examined a fixed-dose combination that pairs an antihistamine with a corticosteroid in one spray. Participants received both drug classes through a single nasal delivery system in the same formulation. That regimen and narrowly defined pediatric population formed the basis for the labeling change.

Children treated with Ryaltris had greater improvement in nasal symptoms than those who received placebo during the 14-day study period. Treatment was reported to be well tolerated among enrolled children throughout follow-up. No numerical effect size was provided in the company summary, so the reported benefit remains directional rather than quantified. These findings summarize the short-term clinical outcomes cited in support of the broader age range.

Each fixed-dose spray contains 665 µg of olopatadine and 25 µg of mometasone furoate in a single intranasal product.

Common adverse reactions listed in the labeling were dysgeusia, epistaxis, and nasal discomfort, each identified among events occurring in at least 1% of patients. Warnings and precautions include epistaxis, nasal ulceration, nasal septal perforation, impaired wound healing, Candida infection, hypersensitivity reactions, immunosuppression with infection risk, glaucoma, cataracts, hypercorticism, adrenal suppression, and somnolence. For pediatric patients receiving corticosteroid-containing treatment, the prescribing information highlights possible reduced growth velocity and states that routine growth monitoring is recommended.