Oyster Point Pharma has received US FDA approval for Tyrvaya (varenicline) nasal spray for dry eye disease (DED).
"The approval of Tyrvaya nasal spray marks a milestone for patients and eyecare 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," said Jeffrey Nau, CEO of Oyster Point Pharma.
Dr Ed Holland, director of cornea services at Cincinnati Eye Institute and professor of ophthalmology at the University of Cincinnati said, "I see many patients in my practice whose lives are impacted by dry eye disease. Tyrvaya nasal spray is a new pharmaceutical approach with a differentiated mechanism of action for the dry eye disease community. Having a product that provides clinically meaningful production of basal tear film as early as four weeks is incredible for the dry eye patient."
A series of clinical trials (ONSET-1, ONSET-2, and MYSTIC) in more than 1,000 patients with mild, moderate or severe dry eye disease demonstrated statistically significant improvements in tear film production as assessed using the anesthetised Schirmer's score (0-35mm) at week four, said Oyster Point Pharma. Of the patients treated with Tyrvaya, 52% achieved ≥10mm increase in Schirmer's score from baseline in the ONSET-1 study, and 47% achieved ≥10mm increase in Schirmer's score from baseline in the ONSET-2 study, compared to 14% and 28% of vehicle-treated patients in the ONSET-1 study and the ONSET-2 study, respectively at week four (p<0.01 in both studies), it reported. The most common adverse reaction, found in 82% of patients, was sneezing, while other events reported in 5-16% of patients were cough, throat irritation and nose irritation.
