Glenmark Pharmaceuticals has announced upcoming presentations of pooled data from clinical studies of Ryaltris™ (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), formerly GSP 301 Nasal Spray, an investigational fixed-dose combination nasal spray for the treatment of seasonal allergic rhinitis (SAR) in patients 12 years of age and older, at the 2019 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI 2019) in San Francisco, California. “Ryaltris” has been conditionally accepted by the FDA as the brand name.

Mahboob Rahman, Chief Medical Officer at Glenmark Pharmaceuticals said, “We continue to evaluate the clinical profile of Ryaltris based on findings from our completed efficacy and safety studies. These new, pooled analyses on key outcomes from thousands of patients provide additional insights into the potential effectiveness of Ryaltris. With the target action date for completion of FDA review of Ryaltris less than two months away, we are pleased for the opportunity to present these data at AAAAI 2019.”

Glenmark Pharmaceuticals has studied Ryaltris in seven clinical trials involving more than 4,000 patients. Results from clinical trials of Ryaltris have been previously presented at key medical meetings.

If approved by the FDA, Ryaltris will be commercialized by Glenmark Therapeutics Inc., USA, a wholly-owned subsidiary of Glenmark Holding, SA, that is dedicated to launching and commercializing a portfolio of branded products in the therapeutic areas of respiratory and dermatology in the United States.