Hikma Launches Ryaltris for Allergic Rhinitis

Ryaltris is a fixed-dose combination therapy that provides relief for both nasal and ocular symptoms of seasonal allergic rhinitis in a nasal spray.

Hikma Pharmaceuticals has launched Ryaltris (olopatadine hydrochloride and mometasone furoate) nasal spray. Ryaltris is approved to treat symptoms of seasonal allergic rhinitis in adult and pediatric patients 12 years of age and older.

“Allergic rhinitis and allergic conjunctivitis are among the most common chronic diseases in the United States today, affecting 60 million Americans each year, yet about one in seven U.S. adults have reported their nasal allergy symptoms are either poorly controlled or not controlled at all, and ocular symptoms are reported to be as severe as nasal symptoms,” Leonard Bielory, M.D., professor of Medicine, Allergy, Immunology and Ophthalmology at Hackensack Meridian School of Medicine, said in a press release. “Ryaltris provides an important new treatment option for patients suffering from this chronic condition affecting the nose and eyes.”

The FDA approved Ryaltris in January 2022. It was developed by Glenmark and licensed to Hikma for marketing and distribution in the United States.

The efficacy and safety of Ryaltris was established in a clinical trial program in more than 4,000 patients with seasonal allergic rhinitis. 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 10 minutes to 15 minutes, across three phase 3 studies. The safety profile is consistent with placebo, monotherapy, and comparator fixed-dose-combination treatment.