Post-marketing safety assessment of Tyrvaya: A real-world pharmacovigilance analysis based on the FDA Adverse Event Reporting System

A preservative-free intranasal formulation of varenicline (Tyrvaya) has been developed and approved in the United States for the treatment of the signs and symptoms of dry eye disease (DED). Given its growing use in the clinical treatment of DED, understanding its safety in real-world settings is essential. This study aims to further assess the safety concerns after the launch of Tyrvaya. This study analyzed all adverse events (AEs) reports from the FDA Adverse Event Reporting System database, in which Tyrvaya was identified as the primary suspected drug, starting from the fourth quarter of 2021, to evaluate its safety in clinical practice. To ensure the accuracy and reliability of the study, we employed 4 types of disproportionality analyses: the reporting odds ratio, proportional reporting ratio, multi-item gamma Poisson shrinker (MGPS), and Bayesian confidence propagation neural network. Additionally, the Weibull distribution was utilized to model the risk of AEs over time. A total of 2178 patients and 5189 reports associated with Tyrvaya administration were collected. Positive signal detection of Tyrvaya at the system organ class level included respiratory, thoracic, and mediastinal disorders, product issues, and eye disorders. At the preferred term level, the AEs listed on the drug label were confirmed, including sneezing, cough, throat irritation, and instillation-site (nasal) irritation. Furthermore, several adverse reactions not listed in the medication leaflet but deemed clinically significant were identified, including blurred vision, burning sensation, upper-airway cough syndrome, nasal ulcers, dysphonia, abnormal dreams, photophobia, and eye swelling. Additionally, we identified potential adverse reactions, including headache, insomnia, and vertigo. This study identified known AEs associated with Tyrvaya and uncovered new AE signals that had not been previously reported. These findings offer clinicians additional safety insights for the use of Tyrvaya in treating DED.