PURPOSE: Lifitegrast ophthalmic solution 5% is indicated for treatment of signs and symptoms of dry eye disease (DED). Lifitegrast demonstrated symptom relief starting at 2 weeks and a favorable safety profile in clinical trials. We report findings from 2 real-world evidence studies, a provider survey and a pharmacovigilance (PV) database analysis.

METHODS: Eyecare providers (ECPs: ophthalmologists and optometrists) completed a survey and submitted case reports on patients treated with lifitegrast. Twelve ECPs treated an average of 1288 patients with DED annually, with 21% of these patients, on average, receiving lifitegrast. Seven ECPs provided 36 case reports of patients (mean age, 51 years; mean number of follow-up visits, 5) with aqueous-deficient (39%), evaporative (14%), or mixed (47%) DED. Postmarketing safety data from approval in the United States (July 2016) to July 10, 2024, were reviewed using a company PV database with reports from providers and patients.

RESULTS: In the survey, two-thirds (67%) of ECPs reported near/complete symptom resolution in patients after 1-3 months of lifitegrast treatment. Case report data indicated that improvement was sustained throughout treatment, with a mean duration of 29 months (range, 1-69). Adverse events (AEs) considered by the ECPs as related to lifitegrast use included blurred vision, burning/stinging, and dysgeusia; all were mild or moderate in severity. In the postmarketing database, cumulative patient exposure with 8 years of worldwide use was estimated at 915,260 patient treatment-years. No new safety signals were identified.

CONCLUSION: Results from the ECP survey show that treatment with lifitegrast provides sustained symptom relief in patients with DED, and the AEs reported were consistent with the known safety profile of lifitegrast. Long-term use revealed no new or changing safety signals during routine safety monitoring.