Health Canada has granted approval for Bausch Health and Glenmark Pharmaceuticals subsidiary Glenmark Specialty ’s Ryaltris (olopatadine hydrochloride and mometasone furoate nasal spray) as a symptomatic therapy for moderate to severe seasonal allergic rhinitis (SAR).
In addition to SAR, the spray is indicated to treat associated ocular symptoms in adults, adolescents and children aged six years and above.
A fixed-dose combination therapy, Ryaltris offers ocular and nasal relief for SAR symptoms through a single, easy-to-use nasal spray.
Bausch Health Europe and Canada senior vice-president Cees Heiman said: “This Health Canada approval will allow Bausch Health to soon make Ryaltris available to Canadians, providing an innovative therapy option for seasonal allergic rhinitis.
“This is part of our ongoing commitment to being a trusted partner in the healthcare of Canadians.”
The therapy’s efficacy and safety were validated in a clinical trials programme carried out by Glenmark in more than 3,000 SAR patients.
According to the findings, twice-a-day dose of Ryaltris offered statistically significant improvement in nasal as well as ocular symptoms compared with a placebo.
Additionally, in three randomised, double-blind Phase III trials, the therapy provided statistically significant action onset in nasal symptom relief at 15 minutes versus placebo.
Ryaltris was also found to have a safety profile in line with those observed in a similar class of intranasal drugs.
Glenmark Pharmaceuticals Global Formulations Business CEO Brendan O’Grady said: “We are very pleased that Bausch Health, Canada, will soon be able to bring the benefits of the novel drug Ryaltris to the patients in Canada seeking a new treatment for seasonal allergic rhinitis.
“Ryaltris is a result of our consistent efforts to offer high-quality medicines that benefit patients around the world, and now coming to Canada, adding to our global respiratory leadership.”
In February, the company, along with SaNOtize Research & Development, launched Nitric Oxide Nasal Spray for use in adult Covid-19 patients in India.