Tyrvaya nasal spray receives FDA approval for treatment of dry eye disease
The FDA approved Tyrvaya nasal spray for the treatment of signs and symptoms of dry eye disease, according to a press release from Oyster Point Pharma.
Tyrvaya (varenicline solution 0.03 mg), formerly called OC-01, is the first approved nasal spray for the treatment of dry eye disease.
“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 the release.
The drug was investigated in the ONSET-1, ONSET-2 and MYSTIC clinical trials in more than 1,000 patients. In these trials, patients treated with Tyrvaya showed statistically significant improvement in tear film production as assessed by Schirmer’s score at week 4.
The most common adverse reaction to the therapy was sneezing, which was reported in 82% of patients. Other mild events, including cough, throat irritation and nose irritation, were reported in 5% to 16% of patients.
Tyrvaya will be available in November.