The Food and Drug Administration has approved Tyrvaya (varenicline solution) nasal spray for the treatment of signs and symptoms of dry eye disease.
Tyrvaya contains varenicline, a highly selective nicotinic acetylcholine agonist, which stimulates natural tear film production by activating the trigeminal parasympathetic pathway in the nasal cavity. Each actuation delivers a 0.05mL spray containing 0.03mg of varenicline.
The approval was based on data from the phase 3 ONSET-2 (ClinicalTrials.gov: NCT04036292), phase 2b ONSET-1 (ClinicalTrials.gov: NCT03636061), and phase 2 MYSTIC trials that included over 1000 patients with mild, moderate or severe symptoms of dry eye disease.
Findings from these trials showed that treatment with Tyrvaya demonstrated statistically significant improvements in Schirmer’s score (a measure of natural tear film production) when compared with control. In the ONSET-1 and ONSET-2 trials, 52% and 47% of patients treated with Tyrvaya, respectively, achieved at least a 10mm increase in tear production from baseline compared with 14% and 28% of patients treated with control (P <.01 in both studies).
The most common adverse reaction reported in 82% of patients treated with Tyrvaya was sneezing; other adverse reactions reported in 5% to 16% of patients were cough, throat irritation, and instillation site (nose) irritation.
Tyrvaya is supplied in a carton containing 2 nasal spray bottles; each bottle contains 60 sprays. The recommended dose is 1 spray into each nostril twice daily.
Tyrvaya is expected to be available in November 2021. The Company will be providing a support program called TEAMTyrvaya for eligible patients with commercial insurance.
- Oyster Point Pharma announces FDA approval of Tyrvaya™ (varenicline solution) nasal spray for the treatment of the signs and symptoms of dry eye disease. News release. Oyster Point Pharma, Inc. Accessed October 18, 2021. https://www.multivu.com/players/English/8955851-oyster-point-pharma-fda-approval-tyrvaya/.
- Tyrvaya. Package insert. Oyster Point Pharma; 2021. Accessed October 18, 2021. https://www.tyrvaya-pro.com/files/prescribing-information.pdf.