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Molecule

Lifitegrast

Lymphocyte Function-Associated Antigen-1 Antagonist
Available on requestOphthalmology
Presentations
2
Brands
1
Manufacturers
1
Available from stock
0

Lifitegrast is a lymphocyte function-associated antigen-1 antagonist indicated for the treatment of the signs and symptoms of dry eye disease (DED). It is available as eye drops and powder for ophthalmic solution. MedsAcross supplies Lifitegrast for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Lymphocyte Function-Associated Antigen-1 Antagonist, Lymphocyte Function-Associated Antigen-1 Antagonists
ATC classification
S01XA25 Lifitegrast · Eye medicines, subgroup S01X, subgroup S01XA
US FDA first approval
11 July 2016
EU status
Application withdrawn
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Ophthalmic
Dosage forms
Eye drops, Powder for ophthalmic solution
Identifiers
UNII 038E5L962WRxCUI 1801820CAS 1025967-78-5DrugBank DB11611Q23044263

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Xiidra ® (lifitegrast ophthalmic solution) 5% is indicated for the treatment of the signs and symptoms of dry eye disease (DED). Xiidra (lifitegrast ophthalmic solution) 5% is a lymphocyte function-associated antigen-1 (LFA-1) antagonist indicated for the treatment of the signs and symptoms of dry eye disease (DED).

Source: US FDA prescribing information

How it works

Lifitegrast binds to the integrin LFA-1, a cell surface protein found on leukocytes and blocks the interaction of LFA-1 with its cognate ligand intercellular adhesion molecule-1 (ICAM-1). ICAM-1 may be overexpressed in corneal and conjunctival tissues in DED. LFA-1/ICAM-1 interaction can contribute to the formation of an immunological synapse resulting in T-cell activation and migration to target tissues. In vitro studies demonstrated that lifitegrast may inhibit T-cell adhesion to ICAM-1 in a human T-cell line and may inhibit secretion of inflammatory cytokines in human peripheral blood mononuclear cells. The exact mechanism of action of lifitegrast in DED is not known.

Source: US FDA prescribing information

Dosing overview

Instill one drop of Xiidra twice daily (approximately 12 hours apart) into each eye using a single-use container. Discard the single-use container immediately after using in each eye. Contact lenses should be removed prior to the administration of Xiidra and may be reinserted 15 minutes following administration. One drop twice daily in each eye (approximately 12 hours apart).

Source: US FDA prescribing information

Contraindications

Xiidra is contraindicated in patients with known hypersensitivity to lifitegrast or to any of the other ingredients in the formulation. Hypersensitivity.

Source: US FDA prescribing information

Side effects

The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity The most common adverse reactions (incidence 5%-25%) following the use of Xiidra were instillation-site irritation, dysgeusia, and decreased visual acuity.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

2 presentations of Lifitegrast, sorted by availability.

MedicineManufacturerRegisterAvailability
Xiidra 50 mg/mL eye dropsOphthalmicBausch & LombUS FDAAvailable on request
Lifitegrast 50 mg/mL powder for ophthalmic solutionOphthalmicGeneric name—US FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 11 July 2016Drugs@FDA
EU (EMA)Application withdrawnEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenWithdrawnEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Lifitegrast available for export from India?

Yes, on request. MedsAcross lists 2 presentations of Lifitegrast and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Lifitegrast have?

The catalogue lists 1 brand names for Lifitegrast, including Xiidra.

Is Lifitegrast approved by the US FDA?

Yes. The US FDA first approved Lifitegrast on 11 July 2016, according to Drugs@FDA.

Does Lifitegrast need cold chain shipping?

No listed presentation of Lifitegrast is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Lifitegrast in?

Lifitegrast is classified under ATC code S01XA25 (Lifitegrast).

References

  1. Xiidra prescribing information (Novartis Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 18 August 2025

Request Lifitegrast for export supply

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