Key Takeaways

  • A phase 4 study found treatment of dry eye disease with varenicline nasal spray (Tyrvaya, Harrow) led to a mean improvement in patients’ dry eye questionnaire score and eye dryness score compared with patients in the vehicle group.
  • The mean change in noninvasive tear break-up time (70% vs 30%) was not significantly different between the groups.
  • In the treatment group, 88% reported sneezing as an adverse event compared with 4% of the vehicle group.

Results from the phase 4 TSUNAMI clinical trial (NCT05514041) of varenicline nasal spray (Tyrvaya, Harrow) for the treatment of dry eye disease (DED) found a statistically significant improvement in the dry eye questionnaire score (DEQS; 23% vs 12%) and eye dryness score (EDS; 44% vs 27%) for patients treated with the varenicline nasal spray compared with the vehicle group.1

In the prospective, placebo-controlled study, 50 patients with DED were randomly assigned to receive either varenicline nasal spray 0.03 mg or its vehicle twice daily for 28 days. In addition to improvements in DEQS and EDS, the researchers noted a statistically significant higher mean corneal and conjunctival fluorescein staining (~50% vs ~20%,) in treated patients versus the vehicle group; while the mean change in noninvasive tear break-up time (70% vs 30%) was not significantly different between the groups, it was higher in the varenicline compared with vehicle (2.02 ± 3.54 vs 1.18 ± 2.42). They found no difference in surface asymmetry index and surface regularity index between the groups.1

All 50 patients completed treatment without discontinuation. All adverse events—such as sneezing (88% of treated patients vs 4% of the vehicle group), burning sensation (three patients in the treatment arm), runny nose (one patient in the treatment arm), and nosebleed (one patient in each group)—were mild and resolved without additional intervention.1

The researchers concluded that the results suggest improving tear production with a nasal spray can help promote tear film stability and ocular homeostasis over time.1

1. Stephenson PD, Matossian C. The effect of varenicline nasal spray on the signs and symptoms of dry eye disease and tear film stability: a randomized controlled trial. Clin Ophthalmol. 2026;20:610688. doi: 10.2147/OPTH.S610688