TYRVAYA

Absorption/

DistributionFollowing administration of 0.12 mg (0.06 mg per 50-µL spray in each nostril), a strength of varenicline that is higher than the labeled concentration, varenicline can be detected in plasma by 5 minutes, generally achieves peak concentration within 2 hours, with a mean C max of 0.34 ng/mL, and has an AUC 0-inf of 7.46 h*ng/mL. The systemic exposure (AUC 0-inf ) following this intranasal dose was approximately 7.5% of the exposure observed following a 1 mg oral dose of var...

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 tre...

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 dru...

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