TheraRadar
Data updated: May 26, 2026

LIFITEGRAST

Ophthalmology Approved 2023-08-04
Jump to: Indications Approvals Trials Competitors Safety Patents
3
Indications
--
Phase 3 Trials
2
Years on Market

Details

Status
None (Tentative Approval)
First Approved
2023-08-04
Routes
OPHTHALMIC
Dosage Forms
SOLUTION/DROPS

Companies

Sun Pharma EUGIA PHARMA INGENUS PHARMS LLC MICRO LABS
Active Ingredient: LIFITEGRAST

LIFITEGRAST Approval History

2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2023 to 2024
Oct 2024 ORIGINAL
Update
FDA Letter
Nov 2023 ORIGINAL
Update
Aug 2023 ORIGINAL
Update
FDA Letter

What LIFITEGRAST Treats

3 FDA approvals

Originally approved for its first indication in 2023 . Covers 3 distinct patient populations.

  • Other (3)
📋

Clinical Trial Registry

12 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
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NCT03408015 300001139 Ph 4 withdrawn Effects of Xiidra on Closed Eye Tear Film Leukocytes in Dry Eye Disease
NCT03431272 F49384759 Ph 4 withdrawn Use of 5.0% Lifitegrast Ophthalmic Solution for the Treatment of Dry Eye Disease in Contact Lens Wearers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

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
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.

LIFITEGRAST FDA Label Details

Looking for the branded version?

XIIDRA

Full clinical data, patents, trials, and competitive landscape for lifitegrast.

See XIIDRA

Data Sources

FDA Approval: ANDA215126 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.