Lifitegrast

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
Lifitegrast Eye Drops in Healthy Subjects：Phase I Study	2025/06/27	NCT07040826	Not Applicable	Completed	Qilu Pharmaceutical Co., Ltd.
Examining the Clinical Characteristics, Treatment Patterns, Real-world Effectiveness, and Healthcare Resource Utilization of Patients With Dry Eye Disease	2023/05/15	NCT05857748	N/A	Withdrawn	Novartis Pharmaceuticals
Treatment Regimens in Meibomian Gland Dysfunction	2022/10/26	NCT05594745	Phase 4	Completed	Tauber Eye Center
Lifitegrast 5% for the Treatment of Dry Eye In Habitual Soft Contact Lens Wearers	2022/08/17	NCT05505292	Phase 4	Completed	State University of New York College of Optometry
An Exploratory Crossover Clinical Trial to Compare the Activity of Reproxalap and Lifitegrast in a Dry Eye Disease Chamber	2021/11/01	NCT05102409	Phase 2	Completed	Aldeyra Therapeutics, Inc.
Efficacy of Xiidra in Dry Eye Disease After Collagen Cross Linking	2021/09/16	NCT05045053	Phase 4	UNKNOWN	Benha University
The Effects and Safety of 5% Lifitegrast Ophthalmic Solution in Subjects With Dry Eye Disease in Ocular Graft-versus-Host Disease	2021/03/11	NCT04792580	Early Phase 1	Completed	Richard W Yee, MD
A Research Study To See How Well an Eye Drop, SURF-100 (A Mycophenolic Acid/Betamethasone Sodium Phosphate Combination), Works and What Side Effects There Are in Subjects With Dry Eye Disease	2021/02/02	NCT04734197	Phase 2	Completed	Surface Ophthalmics, Inc.
The Chronology of Lifitegrast Effect on Anterior Surface Rehabilitation (CLEAR) Study	2020/12/17	NCT04669561	Phase 4	Completed	Research Insight LLC
Xiidra vs. Xiidra + Dextenza Treatment for Dry Eye Disease	2020/06/02	NCT04413253	Phase 4	Terminated	Eye Surgeons of Indiana

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Xiidra	Bausch & Lomb Incorporated	24208-911	OPHTHALMIC	50 mg in 1 mL	1/2/2024
Xiidra	Novartis Pharmaceuticals Corporation	0078-0911	OPHTHALMIC	50 mg in 1 mL	7/31/2020
Lifitegrast	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	Bausch & Lomb Australia Pty Ltd	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.

Related News

FDA Approves First-in-Class TRPM8 Receptor Agonist Tryptyr for Dry Eye Disease Treatment

2 months ago

The FDA approved Tryptyr (acoltremon ophthalmic solution) 0.003%, a first-in-class TRPM8 receptor agonist that stimulates corneal sensory nerves to rapidly increase natural tear production in dry eye disease patients.

Lifitegrast Shows Long-Term Safety and Efficacy for Dry Eye Disease in 7-Year Analysis

3 months ago

A 7-year postmarketing analysis of lifitegrast ophthalmic solution 5% (Xiidra) confirms its favorable safety profile with no new safety signals identified across nearly 800,000 patient treatment years.

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