Retrospective Evaluation of a real-world Short-Term (one month) Treatment with Varenicline Tartrate for Dry Eye Disease

Objective To retrospectively evaluate tear secretion (assessed by Schirmer Test Scores, as performed in anesthetized eyes, SIT) and tear film stability (Tear Break-Up Time, BUT) in dry eye disease (DED) patients following a one month administration of varenicline tartrate nasal spray (trade name: Tyrvaya). Such a protocol may provide a novel option for the short-term treatment of DED. Methods Clinical data from real- world DED patients treated with varenicline tartrate nasal spray at the Shenzhen Hospital of The University of Hong Kong over the period from December 2023 to June 2025 were collected. The inclusion criteria were patients: 1) meeting the diagnostic criteria of the Chinese Expert Consensus on Dry Eye Disease (2024) and 2) that were first-time users of varenicline tartrate nasal spray (0.03 mg) as administered twice a day, with one spray in each nostril. Patients with other ocular diseases (e.g. conjunctivitis, keratitis, acute blepharitis, ocular trauma, ocular surface surgery, etc.) as well as those with untimely and/or missing follow-up data were excluded. Finally, of the initial 140 patients assessed, only 26 (52 eyes) were included for data analyses. These patients consisted of 16 male (32 eyes) and 10 female (20 eyes) patients with an average age of (48.50 ± 14.45) years. Results and Conclusions After one month of varenicline tartrate nasal spray treatment, both SIT and BUT scores were significantly increased over their respective pre-treatment baseline levels. Increases in BUT scores, while statistically significant (P = 0.05), were substantially less than that observed for SIT scores. Accordingly, improvements in SIT were markedly greater than that as obtained for BUT scores. Moreover, a good drug safety level was obtained with this varenicline tartrate nasal spray treatment, suggesting that this protocol can provide a novel approach for a short-term treatment of DED.