Glenmark Specialty S.A. has announced that the U.S. Food and Drug Administration (FDA) has approved the expanded use of RYALTRIS (olopatadine hydrochloride and mometasone furoate) Nasal Spray for the treatment of symptoms of Seasonal Allergic Rhinitis (SAR) in pediatric patients aged 6 to less than 12 years.

With the latest approval, RYALTRIS is now indicated in the United States for both adults and children six years of age and older, extending access to the therapy for a younger pediatric population.

The approval is supported by a Phase III randomized, double-blind, placebo-controlled clinical trial involving 446 children aged 6–11 years with Seasonal Allergic Rhinitis. The study demonstrated that RYALTRIS significantly improved nasal symptoms compared with placebo and was well tolerated during the 14-day treatment period.

According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 25% of children aged 6–11 years were diagnosed with seasonal allergies in 2024. Beyond nasal symptoms, Seasonal Allergic Rhinitis can adversely affect sleep, emotional well-being, physical activity and overall quality of life in children.

Marc Kikuchi, President & Business Head, North America, Glenmark, said, "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 U.S. respiratory portfolio."

Effective April 1, 2026, Glenmark Pharmaceuticals Inc., USA assumed responsibility for the product's end-to-end commercialization and distribution in the United States, including brand strategy, market access, distribution and customer engagement.

RYALTRIS is a fixed-dose combination nasal spray that combines olopatadine hydrochloride, an antihistamine, and mometasone furoate, a corticosteroid, in a single formulation. 

The therapy was first approved by the U.S. FDA in 2022 for adults and pediatric patients aged 12 years and older with Seasonal Allergic Rhinitis.