Lifitegrast 5% Improves All Biomarkers of Dry Eye Disease, Study Suggests

Lifitegrast 5% effectively improves all measured clinical biomarkers of dry eye disease (DED) in adult patients, according to a recent 12-week prospective observational case series study.

Presented at the American Optometric Association’s 2025 Conference, this study, conducted by Adam Alexander, OD, medical director of dry eye and pipeline products at Bausch + Lomb, and colleagues, investigated the efficacy of lifitegrast 5% in DED utilizing common biomarkers and clinical symptoms. DED was defined as an ocular surface disease index (OSDI) ≥25, clinical findings, and osmolarity in at least one eye ≥312mOsm/L.1

Lifitegrast is an antagonist of lymphocyte function-associated antigen-1 (LFA-1), which is found on the surface of lymphocytes. By blocking this antigen from interacting with intercellular adhesion molecule 1 (ICAM-1), lifitegrast prevents an inflammatory response, which results in a reduction in inflammatory mediators and cytokines. It is also thought to increase goblet cell number and area, as well as tear formation.2

Lifitegrast was approved by the US Food and Drug Administration (FDA) for use in DED in 2016. However, the application for market authorization by the European Medicines Agency (EMA) was withdrawn in June 2020 after it did not receive provisional acceptance. The EMA cited concerns of insufficient efficacy evidence at the time. In the US, barriers to lifitegrast’s usage include insurance coverage and cost issues.2

Patients were instructed to use 1 drop of lifitegrast 5% per eye twice daily for the full 12-week period. Investigators assessed patients using the OSDI symptom questionnaire, tear osmolarity assessment, MMP-9 testing, Schirmer tests, tear film breakup time, corneal staining with fluorescein, slit-lamp examinations, meibomian grading, and conjunctival staining with lissamine green. Assessment visits were scheduled at baseline and 2 weeks, 6 weeks, and 12 weeks post-baseline.1

A total of 50 participants were included, with a mean age of 43 years, a baseline OSDI of 52.2 (95% CI, 48-56.5), and a mean tear osmolarity of 317 mOsm/L (95% CI, 314-319). MMP-9 was detected in 36 patients; each patient with MMP-9 exhibited it in both eyes.1

Investigators saw a statistically significant improvement in OSDI from baseline during each visit (week 12 OSDI mean 31.2; 95% CI, 27.5-30; P <.001 versus baseline). Tear osmolarity also saw a statistically significant improvement for each eye and both eyes combined to week 12 (mean 293 mOsm/L; 95% CI, 290-297; P <.001). The team also noted improvements in the Schirmer test (left and right eyes combined: 11.66 mm versus 17.35 mm, P <.001), TBUT (left and right eyes combined: 8.1 versus 10.4; P <.001), fluorescein staining (left and right eyes combined: .27 versus .07; P <.001), and lissamine green testing (left and right eyes combined: 1.03 versus 0.12; P <.001). Improvements were seen as early as visit 2.1

Most eyes exhibited either improvements or no changes in score for silt lamp examinations; no scores reached >1 for any assessment at visit 4. Patients with a 1 or 2 score in any assessment at baseline saw an improvement by visit 4, and 2 patients recorded a worse score by visit 4. No adverse events were reported during the study.1

Based on these data, investigators established the efficacy of lifitegrast 5% in improving all measures of clinical signs and biomarkers of DED by the end of the study.1

“Improvements were seen as early as 2 weeks after treatment initiation, which was the earliest timepoint for which measurements were available, for OSDI and tear osmolarity, and for the hallmark sign of inflammatory DED, which is conjunctival lissamine green staining,” said Alexander.1

References

1. Alexander A, Karpecki P, Donnenfeld E. The Effects of Lifitegrast 5.0% Solution on Clinical Signs and Biomarkers in Dry Eye Disease. Abstract presented at the American Optometric Association 2025 Conference in Minneapolis, Minnesota, June 25-28, 2025.

2. Assi L, Lutfallah SC, Yim TW, Liu SH, Duffy SJ, Weiss J. Topical lifitegrast therapy for dry eye disease. Cochrane Database Syst Rev. 2025;6(6):CD016117. Published 2025 Jun 20. doi:10.1002/14651858.CD016117