Postmarketing Analysis Confirms Safety Profile of Lifitegrast for Dry Eye

Clara C. Chan, MD

Credit: University of Waterloo

A study examining the long-term safety of lifitegrast ophthalmic solution 5% (Xiidra) identified no new or changing signals during routine safety monitoring of patients with dry eye disease (DED) across worldwide postmarketing findings.1

Presented at the 2025 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting, the cumulative patient exposure, involving 7 years of worldwide postmarketing safety data, was estimated at nearly 800,000 patient treatment years—no new safety findings were identified in the database.

“Long-term experience with lifitegrast was not associated with identification of new or changing safety signals during routine safety monitoring,” wrote the investigative team, led by Clara C. Chan, MD, an associate professor of ophthalmology at the University of Toronto and medical director of the Eye Bank of Canada. “These findings support the favorable safety and tolerability profile of lifitegrast in the treatment of patients with DED.”

The US Food and Drug Administration (FDA) gave the nod to Bausch & Lomb’s lifitegrast ophthalmic solution 5% in July 2016 for the treatment of signs and symptoms of DED. A favorable safety profile was reported in five randomized, placebo-controlled trials ranging from 12 weeks to 1 year.The 5 trials included a dose-ranging study and the Phase 3 OPUS-1, OPUS-2, OPUS-3, and SONATA trials.2

For this analysis, postmarketing safety data were evaluated from US approval to July 2023, using the company’s safety database, including reports from patients and providers. Exposure to lifitegrast ophthalmic solution 5% was measured as the patient treatment years and calculated from the total amount of lifitegrast ophthalmic solution 5% worldwide, divided according to 2 single-use containers per patient/day (0.4 mL x 365 days/year).1

Chan and colleagues explored the database using safety terms to note relevant cases, with hypersensitivity a postmarketing adverse event of interest. The team searched terms, including hypersensitivitiy, periorbital swelling, pharyngeal swelling, and erythema to identify relevant cases.

Overall, the reports equaled the number of events of interest and were divided by patient exposure in hundred patient treatment years.

The cumulative patient exposure was estimated at 789,901 patient treatment years across 7 years of safety data. Chan and colleagues identified no new safety signals, no differences between older and younger and adult patients, and no evidence to suggest the need for a dosage regimen adjustment in elderly patients.

Common adverse events identified in clinical trials included eye irritation (0.19 cases per 100 treatment-years), instillation site reaction (0.13 per 100 treatment-years), eye pain (0.07 per 100 treatment-years), blurred vision (0.23 per 100 treatment-years), and dysgeusia (0.08 per 100 treatment-years). Notably, the analysis showed a low hypersensitivity reporting rate, with 0.19 cases per hundred patient treatment years.

“There were no new safety findings in the database,” Chan and colleagues wrote. “No overall differences in safety or effectiveness have been observed between elderly and younger adult patients. No evidence from available data suggests that a dosage regimen adjustment is required in elderly patients.”

References

1. Chan CC, Quint JM, Ratay M, et al. Safety of Lifitegrast in Patients with Dry Eye Disease: Analysis of a Postmarketing Database. Poster presented at the 2025 American Society of Cataract and Refractive Surgery (ASCRS) Annual Meeting. April 25-28, 2025. Los Angeles, CA.

2. Commissioner O of the. FDA approves new medication for dry eye disease. U.S. Food and Drug Administration. July 12, 2016. Accessed April 25, 2025. https://www.fda.gov/news-events/press-announcements/fda-approves-new-medication-dry-eye-disease#:~:text=The%20U.S.%20Food%20and%20Drug,Monday%2C%20July%2011%2C%202016.