XIIDRA (lifitegrast)
Xiidra is an ophthalmic solution that treats the various signs and symptoms associated with dry eye disease. It helps patients with this condition by targeting specific proteins involved in the inflammatory process on the surface of the eye. Doctors prescribe this medication to address both the physical findings and the subjective discomfort that characterize dry eye.
How XIIDRA Works
Lifitegrast works by binding to LFA-1, a protein on the surface of white blood cells, to block its interaction with ICAM-1. This interference prevents the formation of an immunological synapse, which reduces T-cell activation and their movement into eye tissues. By inhibiting these interactions, the drug helps decrease the secretion of inflammatory cytokines and limits T-cell adhesion.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2016-07-11
- Patent Cliff
- 2033
- Routes
- OPHTHALMIC
- Dosage Forms
- SOLUTION/DROPS
XIIDRA Approval History
What XIIDRA Treats
1 indicationsXIIDRA is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Dry Eye Disease
XIIDRA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in XIIDRA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications XIIDRA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to XIIDRA
3 of 5FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
13 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07128628 | BL-RX01-OPUSNG-1201 | Ph 2 | recruiting | A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease |
| NCT07040826 | QL-YJ1-039-101 | Ph 1 | completed | Lifitegrast Eye Drops in Healthy Subjects：Phase I Study |
| NCT04297618 COLLIE results posted | 41189 | Ph 4 | completed | The Effect of Xiidra on Comfort and Dryness in Symptomatic Contact Lens Wearers |
| NCT00926185 results posted | 1118-KCS-100 | Ph 2 | completed | A Study Evaluating the Efficacy of SAR 1118 (0.1%, 1.0%, 5.0%) Ophthalmic Solution in Subjects With Dry Eye Conducted in a Controlled Adverse Environment (CAE) |
| NCT01743729 results posted | 1118-DRY-300 | Ph 3 | completed | A Phase 3 Study to Evaluate the Efficacy of Lifitegrast in Subjects With Dry Eye |
| NCT00882687 results posted | 1118-ACJ-100 | Ph 2 | completed | Efficacy Study to Evaluate the Effectiveness of 3 Concentrations of SAR 1118 in Allergic Conjunctivitis |
| NCT02284516 OPUS-3 results posted | SHP606-304 | Ph 3 | completed | A Study to Evaluate Efficacy and Safety of Lifitegrast in Subjects With Dry Eye (OPUS-3) |
| NCT01421498 OPUS-1 results posted | 1118-KCS-200 | Ph 3 | completed | Safety and Efficacy Study of SAR 1118 to Treat Dry Eye Conducted in a Controlled Adverse Environment (CAE) (OPUS-1) |
| NCT01636206 SONATA results posted | 1118-DRY-400 | Ph 3 | completed | Safety Study of Lifitegrast to Treat Dry Eye |
| NCT03408015 | 300001139 | Ph 4 | withdrawn | Effects of Xiidra on Closed Eye Tear Film Leukocytes in Dry Eye Disease |
| NCT03431272 | F49384759 | Ph 4 | withdrawn | Use of 5.0% Lifitegrast Ophthalmic Solution for the Treatment of Dry Eye Disease in Contact Lens Wearers |
| NCT03686878 | LF5-CLD | Ph 4 | completed | Lifitegrast 5% Ophthalmic Solution and Contact Lens Dryness |
| NCT03451396 Lifitegrast | 5720 | Ph 4 | completed | Effect of Lifitegrast on Dry Eye Disease Signs and Symptoms |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
XIIDRA FDA Label Details
Indications & Usage
FDA Label (PDF)XIIDRA is indicated for the treatment of Dry Eye Disease.
XIIDRA Patents & Exclusivity
Patents (10 active)
Pro Intelligence Preview
Deep insights for XIIDRA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 10 active patents
Trial Analysis
- • 15 total trials
- • Stage: Declining
Competitive Landscape
- • 5 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment