RYALTRIS®, a new combination prescription nasal spray for moderate to severe seasonal allergic rhinitis (SAR), now available across Canada

New treatment from Bausch Health, Canada indicated to treat seasonal allergy and associated ocular symptoms in adults, adolescents and children 6 years and older

LAVAL, QC, May 3, 2023 /CNW/ - Bausch Health Companies Inc. (NYSE: BHC) (TSX: BHC) is pleased to announce the availability across Canada of its new prescription treatment RYALTRIS^® (olopatadine hydrochloride and mometasone furoate nasal spray).

RYALTRIS has been approved by Health Canada for the symptomatic treatment of moderate to severe seasonal allergic rhinitis (SAR) and associated ocular symptoms in adults, adolescents, and children aged 6 years and older.¹

"Bausch Health is very pleased that we are now able to make RYALTRIS available to Canadians, providing an innovative new combination nasal spray treatment for SAR, which impacts the lives of the over 9 million Canadians who suffer from SAR or seasonal allergies often referred to as hay fever,²" said Cees Heiman, Senior Vice-President, Europe and Canada, Bausch Health. "The launch of this new therapy adds to our broad portfolio of treatments that further establishes Bausch Health as a trusted partner in the healthcare of Canadians."

"Allergic rhinitis is a common disorder that often doesn't respond adequately to usual treatments" said Dr. Paul Keith, Professor, Division of Clinical Immunology and Allergy, Department of Medicine, McMaster University. "Nasal congestion, nasal itch, runny nose and sneezing are classic symptoms of the disorder. Having a treatment, like RYALTRIS, that provides both a quick onset of symptomatic relief as well as an anti- inflammatory effect for moderate to severe seasonal allergic rhinitis and the associated ocular symptoms can really improve health outcomes and quality of life in adults, adolescents, and children aged 6 years and older."

RYALTRIS is a fixed-dose combination therapy that combines two best-in-class anti-allergy products – the corticosteroid mometasone and the antihistamine olopatadine³ – to give rapid and sustained relief from the symptoms of SAR, both nasal and ocular, in one easy-to-use nasal spray at a competitive price. The onset of action for nasal symptom relief occurs within 15 minutes after administration of RYALTRIS.¹

About RYALTRIS^®

The efficacy and safety of RYALTRIS^® were established in a clinical studies program conducted by Glenmark Pharmaceuticals Ltd., its developers, in over 4300 healthy and allergic rhinitis patients with SAR. Twice-daily RYALTRIS provided statistically significant improvement in both nasal and ocular symptoms vs. placebo, as well as statistically significant onset of action in nasal symptom relief vs. placebo at 15 minutes, across three randomized, double-blind phase 3 studies (P<0.05). The safety profile of RYALTRIS is typical of that observed with intranasal drugs of the same classes.¹

Important Safety Information for Ryaltris^®

RYALTRIS^® is an intra-nasal spray and should not be administered orally, instilled in the eyes, ears or applied to the skin. In 14-day clinical studies of patients with SAR taking RYALTRIS twice a day, the most common adverse events observed were altered taste (3%), nose bleeds (1%) and nasal discomfort (1%). RYALTRIS should not be used by anyone who has had an allergic reaction to olopatadine or mometasone or to any ingredient in the formulation or have untreated fungal, bacterial, or tuberculosis infections of the respiratory tract. Close medical supervision is required in anyone who has a weakened immune system, including those who have had infections with opportunistic pathogens. Increased risk of occurrence or potential worsening of pre-existing infections (e.g., tuberculosis) with fungi, bacteria or viruses can occur, including fatal chickenpox, measles and herpes infections in susceptible patients. RYALTRIS should be used under close medical supervision in anyone who has had nose bleeds or nasal perforation. Recurrence, worsening or persistence of these nasal problems can occur. The effect of RYALTRIS on pregnancy and through transmission in breast milk is not known. Talk to your doctor if you are pregnant, plan to become pregnant or breastfeeding, to ensure it is safe for you to use.¹

About Bausch Health

Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global diversified pharmaceutical company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of products primarily in gastroenterology, hepatology, neurology, dermatology, international pharmaceuticals and eye health, through our controlling interest in Bausch + Lomb. With our leading durable brands, we are delivering on our commitments as we build an innovative company dedicated to advancing global health. For more information, visit www.bauschhealth.com and connect with us on Twitter and LinkedIn.

Bausch Health, Canada Inc.'s prescription treatment portfolio is focused on dermatology, gastrointestinal and cardio-metabolic conditions. Bausch Health also has two manufacturing facilities for prescription pharmaceuticals in Canada, in Laval, Quebec, and Steinbach, Manitoba. More information can be found at the Company's website at www.bauschhealth.ca.

About Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Ltd. (BSE: 532296 | NSE: GLENMARK) is an innovation–driven, global pharmaceutical company with a presence across Branded, Generics, and OTC segments; with a focus on therapeutic areas of respiratory, dermatology and oncology. The company has 10 world–class manufacturing facilities spread across 4 continents, and operations in over 80 countries. In Vivo/Scrip 100 positions Glenmark amongst the Top 100 Companies Ranked by R&D and Pharmaceutical Sales, 2021; while Generics Bulletin/In Vivo places it in the Top 50 Generics and Biosimilars Companies Ranked by Sales, 2021. The company has been Great Place To Work® Certified™ in India, in 2023. Glenmark has impacted over 2.6 million lives over the last decade through its CSR interventions. For more information, visit www.glenmarkpharma.com. Follow us on LinkedIn (Glenmark Pharmaceuticals) and Instagram (glenmark_pharma).

REFERENCES

^{RYALTRIS® is a registered trademark of Glenmark Specialty S.A., used under license.}

¹ Bausch Health, Canada, RYALTRIS^® Product Monograph, dated September 21, 2022.

² Asthma Canada, Allergies: Understand and Manage Your Allergies, How Common Are Allergies? p. 5 https://asthma.ca/wp-content/uploads/2020/06/BreatheEasy-Allergies_optimized_EN.pdf

³ IQVIA Compuscript Audit, MAT October 2022

SOURCE Bausch Health

Bausch Health Companies, Investor Contact: Mark Maico, [email protected], [phone], [phone] (toll free); Media Contact: Kevin Wiggins, [email protected], [phone]