NDAOPHTHALMICSOLUTION/DROPSPriority Review
Approved
Jul 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
11
Data completeness
5/8 — Partial
Priority Review
XIIDRA (lifitegrast) by Bausch + Lomb is lymphocyte function-associated antigen-1 antagonists [moa]. First approved in 2016.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
XIIDRA (lifitegrast) is a small-molecule lymphocyte function-associated antigen-1 (LFA-1) antagonist administered as an ophthalmic solution for dry eye disease. It reduces inflammation by blocking T-cell trafficking to the ocular surface, addressing a key pathophysiological mechanism in dry eye. Patients instill the drops twice daily directly into the affected eye(s).
$0.473BPart D
PeakStable
7.2 years to LOEPeak-stage product with $473M in annual Part D spending indicates an established market presence; brand team is focused on retention and market share defense against emerging competitors.
Mechanism of Action
Lymphocyte Function-Associated Antigen-1 Antagonists
Pharmacologic Class:
Lymphocyte Function-Associated Antigen-1 Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (11)
This is a Single Center, Open-label Prospective Study to Evaluate the Effect of Xiidra® (Lifitegrast Ophthalmic Solution 5.0%) on Tear Film Biomarkers in Dry Eye
Started Mar 2026
36 enrolled
Ocular Surface DiseaseDry Eye Syndrome (DES)
A Study to Assess the Long-Term Safety of Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination in Subjects With Dry Eye Disease
Started Dec 2025
0Dry Eye Disease
Lifitegrast Eye Drops in Healthy Subjects：Phase I Study
Started Dec 2022
24 enrolled
Dry Eye Syndromes
The Effects and Safety of 5% Lifitegrast Ophthalmic Solution in Subjects With Dry Eye Disease in Ocular Graft-versus-Host Disease
Started Oct 2022
30 enrolled
Graft-versus-host-diseaseOcular Graft-versus-host Disease
Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers
Started Sep 2022
32 enrolled
Dry Eye
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.