USFDA Approves Expanded Pediatric Use of Glenmark's RYALTRIS Nasal Spray
New Delhi: Glenmark Specialty S.A. on Monday said the US Food and Drug Administration (USFDA) has approved the expanded use of its 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 adults and children aged 6 years and above, extending its use to a younger pediatric population.
The approval was supported by a Phase III randomized, double-blind, placebo-controlled study involving 446 children aged 6 to 11 years with Seasonal Allergic Rhinitis. According to the company, the study showed that RYALTRIS significantly improved nasal symptoms compared with placebo and was well tolerated during the 14-day treatment period.
Commenting on the development, Marc Kikuchi, President & Business Head, North America, said the approval expands access to RYALTRIS for younger children with Seasonal Allergic Rhinitis and strengthens the product's position within Glenmark's respiratory portfolio in the US.
He added that Glenmark's transition to direct commercialization of RYALTRIS in the United States enables closer engagement with healthcare professionals and patients while supporting the company's plans to expand the brand's presence in the specialty market.
Effective April 1, 2026, Glenmark Pharmaceuticals Inc., USA assumed responsibility for the end-to-end commercialization and distribution of RYALTRIS in the United States, including brand strategy, market access, distribution and customer engagement.
RYALTRIS is a fixed-dose combination nasal spray comprising olopatadine hydrochloride, an antihistamine, and mometasone furoate, a corticosteroid. The therapy was first approved by the USFDA in 2022 for treating Seasonal Allergic Rhinitis in adults and pediatric patients aged 12 years and older.
The company said RYALTRIS has received approvals in several international markets, including the European Union, the United Kingdom, Australia, South Korea, Russia and China. During FY26, the product was launched in 11 additional markets, expanding its global presence to 56 countries.
