FDA approves Tyrvaya Nasal Spray for dry eye disease
This is the first and only nasal spray approved for the treatment of the signs and symptoms of dry eye disease.
The U.S. Food and Drug Administration has approved Tyrvaya (varenicline solution; Oyster Point Pharma, Inc) Nasal Spray 0.03 mg for the treatment of the signs and symptoms of dry eye disease, according to a press release.
The nose spray is delivered twice per day into each nostril to activate basal tear production.
Tyrvaya was evaluated in >1000 patients with mild, moderate, or severe dry eye disease in the ONSET-1, ONSET-2, and MYSTIC clinical trials. Patients treated with Tyrvaya demonstrated statistically significant improvements in tear film production at week 4. In addition, 52% achieved ≥10 mm increase in Schirmer’s score from baseline in the ONSET-1 study compared to 14% of vehicle-treated patients and 47% achieved ≥10 mm increase in Schirmer’s score from baseline in the ONSET-2 study compared to 28% of vehicle-treated patients at week 4.
At week 4 in the ONSET-1 study and ONSET-2 study, Tyrvaya-treated patients had a mean change in Schirmer’s score was 11.7 mm and 11.3 mm as compared to 3.2 mm and 6.3 mm in the vehicle-treated patients.
In the Controlled Adverse Environment, patients treated with Tyrvaya (n = 45) had a mean change from baseline in Eye Dryness Score of -16.0 compared to -4.4 mm in vehicle- treated patients (n = 42) in ONSET-1 at week 3. This endpoint was met (P < 0.01).
In ONSET-2, the observed mean change from baseline in Eye Dryness Score was -10.3 mm in patients treated with Tyrvaya (n = 187) compared to -7.4 mm in vehicle-treated patients (n = 169) at week 4. This endpoint was not met (P > 0.05).
The most common adverse reaction was sneezing in 82% of patients. Cough, throat irritation, and instillation-site (nose) irritation were reported in 5- 16% of patients.
“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 in a press release. “In any therapeutic area, it’s always an exciting moment when you follow the science and develop a truly innovative pharmaceutical treatment option for patients that addresses an important unmet medical need. In conjunction with the FDA, it has been an honor to work alongside my colleagues at Oyster Point to bring Tyrvaya Nasal Spray to the dry eye disease community. We look forward to making Tyrvaya Nasal Spray available to eye care professionals and their patients.”
Read the full press release here.