Oyster Point Pharma announced that the FDA has approved Tyrvaya (varenicline solution) Nasal Spray 0.03 mg, formerly called OC-01, for the treatment of the signs and symptoms of dry eye disease.
The approval marks the first and only nasal spray approved for the treatment of dry eye disease.
The nasal spray is a highly specific cholinergic agonist that is sprayed into each nostril twice daily to trigger basal tear production.
The use of a nasal spray to treat dry eye disease is a novel technique to avoid administrating medication onto an already irritated ocular surface.
In addition, nasal delivery may allow some patients who have difficulty independently administering topical eye drops to administer independently their prescribed dry eye disease therapy.
"The approval of Tyrvaya Nasal Spray marks a milestone for patients and eye care professionals by providing a new drug treatment option for the signs and symptoms of dry eye disease with a differentiated route of administration that is believed to leverage a nerve pathway that can be accessed within the nose," Jeffrey Nau, PhD, MMS, president and CEO of Oyster Point Pharma, said in a company news release.
The drug was tested in over 1,000 patients in the ONSET-1, ONSET-2, and MYSTIC clinical studies.
According to Schirmer's score at week 4, individuals treated with Tyrvaya exhibited statistically significant improvement in tear film generation in these trials.
Sneezing was the most common adverse effect to the medication, reported by 82% of patients. Other minor side effects such as cough, throat irritation, and nose irritation were reported by 5% to 16% of patients.
Tyrvaya Nasal Spray will be available in November 2021 in cartons containing two multidose nasal spray bottles with a prescription.
Each nasal spray bottle provides 15 days of treatment when sprayed twice daily into each nostril. Eye care providers will also receive samples that give 15 days of treatment.