PURPOSE: In patients with dry eye disease, lifitegrast ophthalmic solution 5% (Xiidra) was shown to have a favorable safety profile in 5 randomized, placebo-controlled trials ranging in duration from 12 weeks to 1 year. The majority of ocular adverse events were mild and transient. This postmarketing study examined the long-term safety of lifitegrast.

METHODS: Postmarketing safety data were evaluated from approval in the United States (July 2016) to July 10, 2023, using a company safety database that included reports from providers and patients. Patient exposure was reported as patient treatment years and calculated as the total amount of lifitegrast sold worldwide, divided by 2 single-use containers per patient/day (0.4 mL x 365 days/year). The company database was searched using safety terms of interest (eg, "hypersensitivity"; MedDRA version 26.0) to identify relevant cases. The reporting rate is equal to the number of events of interest divided by patient exposure in hundred patient treatment years.

RESULTS: The cumulative patient exposure with 7 years of worldwide postmarketing safety data was estimated at 789,901 patient treatment years. There were no new safety findings in the database. No overall differences in safety or effectiveness have been observed between elderly and younger adult patients. No evidence from available data suggest that a dosage regimen adjustment is required in elderly patients. The hypersensitivity reporting rate was low: 0.19 cases per hundred patient treatment years.

CONCLUSIONS: Long-term experience with lifitegrast was not associated with identification of new or changing safety signals during routine safety monitoring. These findings support the favorable safety and tolerability profile of lifitegrast in the treatment of patients with dry eye disease.