Tyrvaya

1 INDICATIONS AND USAGE TYRVAYA (varenicline solution) nasal spray is indicated for the treatment of the signs and symptoms of dry eye disease. TYRVAYA (varenicline solution) nasal spray is a cholinergic agonist indicated for the treatment of the signs and symptoms of dry eye disease. ( 1 )

2 DOSAGE AND ADMINISTRATION • One spray in each nostril twice daily (approximately 12 hours apart). ( 2.1 ) • Prime with seven (7) actuations before initial use. Re-prime with 1 actuation if not used for more than five (5) days. ( 2.2 ) 2.1 Dosing Information Spray TYRVAYA once in each nostril twice daily (approximately 12 hours apart). If a dose is missed, resume regular dosing at the next scheduled dose time. 2.2 Priming Instructions Priming : Prime TYRVAYA before initial use by pumping seven (7) actuations into the air away from the face. When TYRVAYA has not been used for more than 5 days, re-prime with 1 spray into the air. Do not shake.

6 ADVERSE REACTIONS The most common adverse reaction reported in 82% of patients was sneezing. Events that were reported in 5-16% of patients were cough, throat irritation, and instillation-site (nose) irritation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Oyster Point Pharma at 1-877-EYE-0123 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In three clinical studies of dry eye disease conducted with varenicline solution nasal spray, 349 patients received at least 1 dose of TYRVAYA. The majority of patients had 31 days of treatment exposure, with a maximum exposure of 105 days. The most common adverse reactions reported in 82% of TYRVAYA treated patients was sneezing. Other common adverse reactions that were reported in >5% of patients include cough (16%), throat irritation (13%), and instillation-site (nose) irritation (8%).

No interactions listed. Consult your pharmacist.

16.2 Storage and Handling • Store TYRVAYA nasal spray at 20°C to 25°C (68°F to 77°F). Do not freeze. • Discard TYRVAYA nasal spray bottle 30 days after opening bottle.