FDA Approves Tyrvaya for Dry Eye Disease

The FDA has approved Tyrvaya (varenicline solution) Nasal Spray 0.03 mg for the treatment of the signs and symptoms of dry eye disease. Developed by Oyster Point Pharma, it is the first nasal spray approved for this indication.

The therapy is believed to bind to cholinergic receptors to activate the trigeminal parasympathetic pathway resulting in increased production of basal tear film as a treatment for dry eye disease.

Tyrvaya is a highly selective cholinergic agonist delivered twice daily as an aqueous nasal spray into each nostril to activate basal tear production. Nasal spray administration provides a new way to treat dry eye disease. Nasal delivery may allow some patients who have difficulty independently administering topical eye drops.

The approval was based on three clinical trials with more than 1,000 patients with mild, moderate, or severe dry eye. Of the patients treated, 52% achieved ≥10 mm increase in Schirmer’s score from baseline in the ONSET-1 study, and 47% achieved ≥10 mm increase in Schirmer’s score from baseline in the ONSET-2 study.

Ed Holland, M.D.

The most common adverse reaction reported in 82% of patients was sneezing. Events that were reported in 5% to 16% of patients were cough, throat irritation, and instillation-site (nose) irritation.

Tyrvaya will be available in November 2021 in cartons containing two multidose nasal spray bottles. Each nasal spray bottle covers treatment for 15 days, administered twice daily into each nostril.

“I see many patients in my practice whose lives are impacted by dry eye disease. Having a product that provides clinically meaningful production of basal tear film as early as four weeks is incredible for the dry eye patient,” Ed Holland, M.D., director of Cornea Services at Cincinnati Eye Institute and professor of Ophthalmology at the University of Cincinnati, said in a statement.

Dry eye disease is a chronic condition that impacts an estimated 38 million people in the United States.