Lifitegrast

(Xiidra®)

Lifitegrast

Drug updated on 9/4/2024

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

Indication

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

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Summary
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  • Xiidra (lifitegrast) is indicated for the treatment of the signs and symptoms of dry eye disease (DED).
  • This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
  • Lifitegrast demonstrated statistically significant improvements in multiple clinical outcomes for patients with dry eye disease (DED), including Total Corneal Staining Score (TCSS), Nasal Lissamine Staining Score (NLSS), Tear Break-Up Time (TBUT), Ocular Discomfort Score (ODS), Eye Discomfort Score (EDS), and Ocular Surface Disease Index Score (OSDI-S).
  • Large multicenter trials reported lifitegrast's statistical superiority in either a symptom or sign endpoint compared to control groups; however, none of the drugs, including lifitegrast, achieved statistical significance for both a sign and symptom endpoint within the same trial.
  • The reviewed studies did not highlight effectiveness outcomes for specific population subgroups or different population types, focusing instead on the general adult population with DED.
  • Lifitegrast was associated with a higher risk of mild to moderate ocular and non-ocular treatment-emergent adverse events (TEAEs), including instillation site discomfort and dysgeusia, which were more common in the lifitegrast group compared to placebo; however, most adverse events were considered tolerable with extremely rare withdrawals due to TEAEs.
  • Ocular discomfort upon instillation, such as burning/stinging and ocular irritation, was a common adverse event for lifitegrast, similar to other approved drugs, with no specific subgroups identified as being at higher risk.

Product Monograph / Prescribing Information

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

Systematic Reviews / Meta-Analyses