Drug updated on 4/26/2024

Dosage FormSolution (topical; 50 mg/mL [5%])
Drug ClassLymphocyte function-associated antigen-1 antagonists
Ongoing and
Completed Studies


  • Indicated for the treatment of the signs and symptoms of dry eye disease (DED).

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  • Lifitegrast (Xiidra) is indicated for the treatment of signs and symptoms of dry eye disease (DED), acting as a T-cell integrin antagonist. It has demonstrated superiority to placebo in improving various scores such as inferior corneal staining score, total corneal staining score, nasal lissamine staining score, ocular discomfort score, eye discomfort score, eye dryness score, and tear break-up time.
  • Two systematic reviews/meta-analyses were examined regarding the use of lifitegrast in DED. The population types or subgroup considerations were not specifically detailed within these studies.
  • When compared with other approved drugs for DED like cyclosporine A cationic emulsion and diquafosol among others, none achieved statistical significance for both a sign and symptom endpoint versus control treatment within the same published study except for lifitegrast, which demonstrated statistical superiority in either symptom or sign endpoint against the control group in large multicenter trials.
  • This indicates that lifitegrast may have an advantage over its contemporaries in terms of efficacy towards certain symptoms or signs of DED, based on repeated evidence from structured studies.
  • Regarding the safety profile derived from the studies, lifitegrast was associated with mild to moderate level treatment-emergent adverse events mainly including instillation site discomfort and dysgeusia, but this incidence rate was not significantly different than those observed with placebos, indicating its tolerability similar to other options for treating DED where the most common side effects also relate to ocular discomfort upon instillation, such as a burning/stinging sensation, etc.
  • Despite showing higher risks overall for treatment-emergent adverse events compared to placebo groups, lifitegrast can be considered a meaningful option, particularly for patients suffering from refractory cases aiming at improved quality of life, while paying attention to possible side effects like dysgeusia and instillation site pain.

Product Monograph / Prescribing Information

Document TitleYearSource
Xiidra (lifitegrast) prescribing information.2020Novartis Pharmaceuticals Corporation, East Hanover, NJ

Systematic Reviews / Meta-Analyses