Overview
Lifitegrast is a FDA approved drug for the treatment of keratoconjunctivitis sicca (dry eye syndrome). It is a tetrahydroisoquinoline derivative and lymphocyte function-associated antigen-1 ( LFA-1) antagonist that was discovered through the rational design process. The ophthalmic solution was approved in July, 2016 under the trade name Xiidra. It has shown to protect the corneal surface and alleviate the symptoms of dry eye syndrome with fast onset of action and well tolerated profile in both local and systemic setting .
Indication
适用于治疗干眼病（DED）的症状和体征。
Associated Conditions
- Dry Eye Syndrome (DES)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/27 | Not Applicable | Completed | |||
2023/05/15 | N/A | Withdrawn | |||
2022/10/26 | Phase 4 | Completed | Tauber Eye Center | ||
2022/08/17 | Phase 4 | Completed | State University of New York College of Optometry | ||
2021/11/01 | Phase 2 | Completed | |||
2021/09/16 | Phase 4 | UNKNOWN | |||
2021/03/11 | Early Phase 1 | Completed | Richard W Yee, MD | ||
2021/02/02 | Phase 2 | Completed | |||
2020/12/17 | Phase 4 | Completed | |||
2020/06/02 | Phase 4 | Terminated | Eye Surgeons of Indiana |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Bausch & Lomb Incorporated | 24208-911 | OPHTHALMIC | 50 mg in 1 mL | 1/2/2024 | |
| Novartis Pharmaceuticals Corporation | 0078-0911 | OPHTHALMIC | 50 mg in 1 mL | 7/31/2020 | |
| Aurobindo Pharma Limited | 59651-450 | OPHTHALMIC | 50 mg in 1 mL | 11/13/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| XIIDRA lifitegrast 50 mg/mL eye drops single-use ampoules | 293589 | Medicine | A | 1/21/2019 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| XIIDRA | bausch & lomb inc | 02471027 | Solution - Ophthalmic | 5 % / W/V | 2/12/2018 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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