The US Food and Drug Administration (FDA) has approved Oyster Point Pharma’s TYRVAYA (varenicline solution) Nasal Spray for the treatment of dry eye disease signs and symptoms.
The TYRVAYA nasal spray is claimed to be the first approved nasal spray to treat dry eye disease.
It is a highly selective cholinergic agonist that is administered twice a day as an aqueous nasal spray into each nostril to activate basal tear production.
The spray activates the trigeminal parasympathetic pathway, which in turn increases production of basal tear film.
Additionally, TYRVAYA nasal spray will benefit the patients who struggle to administer topical eye drops independently.
Oyster Point Pharma president and CEO Jeffrey Nau said: “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.”
The use of TYRVAYA was assessed in the ONSET-1, ONSET-2, and MYSTIC clinical studies in more than 1,000 patients suffering with mild, moderate or severe dry eye disease.
In the ONSET-1 trial, the mean change from baseline in Eye Dryness Score at week 4 in the clinic environment was -5.4 mm in vehicle-treated patients and -18.9 mm in TYRVAYA-treated patients. The endpoint was met.
The company stated that the mean change from baseline in Eye Dryness Score at week 4 was -19.8 mm in TYRVAYA-treated patients and -15.4 mm in vehicle-treated patients in ONSET-2 trial.
The secondary endpoint was not met as the controlled adverse environment (CAE) endpoint was not statistically significant.
Sneezing was the most common adverse reaction reported in 82% of the patients.
TYRVAYA Nasal Spray will be made available with a prescription from next month.