Liftear5%

Liftear ophthalmic solution is indicated for the treatment of the signs and symptoms ofdry eye disease (DED) in adults. This is the established, FDA-approved indication for Liftear.

• Established/FDA-approved use: Treatment of signs and symptoms (including ocular discomfort) of dry eye disease in adult patients.

Liftear is a topical anti-inflammatory therapy and is not used as an immediate lubricant; it works byreducing the T-cell mediated inflammation that underlies chronic dry eye disease. It is not indicated forother ocular surface conditions, and no guideline-supported or off-label uses are well established at this time.

Each mL of Lifitegrast ophthalmic solution contains Lifitegrast 5% (50 mg/mL) as the active ingredient.

Inactive ingredients typically include sodium chloride, sodium thiosulfate pentahydrate, sodiumphosphate, citric acid monohydrate, and purified water, with hydrochloric acid and/or sodium hydroxideused to adjust pH.

Liftear is a lymphocyte function-associated antigen-1 (LFA-1) antagonist formulated as asterile, topical ophthalmic solution for the treatment of dry eye disease. It represents a class oftargeted anti-inflammatory ocular therapy distinct from artificial tears or lubricating drops, as itaddresses an underlying inflammatory mechanism of dry eye rather than simply supplementing tear film.

Liftear is supplied as a single-use vial (or multi-dose bottle, depending on local packaging) forinstillation directly into the affected eye(s).

Ophthalmic anti-inflammatory agent; LFA-1 (lymphocyte function-associated antigen-1) antagonist — Liftear is used specifically for dry eye disease.

Lifitegrast is a lymphocyte function-associated antigen-1 (LFA-1) antagonist. LFA-1 is a cellsurface protein found on leukocytes, and its interaction with intercellular adhesion molecule-1 (ICAM-1) cancontribute to the formation of an immunological synapse, resulting in T-cell activation and migration totarget tissues. ICAM-1 is overexpressed in the corneal and conjunctival tissue of patients with dry eyedisease. In vitro, Lifitegrast inhibits T-cell adhesion to ICAM-1 and blocks the interaction of LFA-1 withICAM-1, thereby reducing the recruitment and activation of T-cells thought to contribute to theinflammation associated with dry eye disease.

Following topical ocular administration of Lifitegrast, systemic exposure is low; plasma concentrations inclinical studies were generally at or near the lower limit of quantification, indicating minimal systemicabsorption from the eye.

Liftear is for topical ophthalmic (eye) use only. Wash hands before use. Tilt the head back, pull downthe lower eyelid to form a small pocket, and instill one drop into the pocket without letting thedropper tip touch the eye, eyelid, or any other surface, to avoid contamination. Remove contact lensesbefore instilling Liftear and wait as directed on the product instructions before reinserting them.

No formal, clinically significant drug-drug interaction studies have identified major systemicinteractions with Liftear, which is consistent with its minimal systemic absorption following topicalocular administration.

• Other topical ophthalmic products: If using other eye drops or ointments concurrently with Liftear, administer them at least 5 minutes apart to avoid one product washing out the other.
• Contact lenses: Liftear contains a preservative (benzalkonium chloride is commonly used in ophthalmic solutions of this class) that may be absorbed by soft contact lenses; remove lenses before use and reinsert only after the waiting period specified in product labeling.

The most commonly reported adverse reactions with Liftear (reported in a meaningful proportion ofpatients in clinical trials) include:

• Instillation-site irritation (a stinging or burning sensation upon application)
• Dysgeusia (an unusual or unpleasant taste sensation, typically shortly after instillation)
• Reduced visual acuity (transient blurring)
• Other eye irritation, discomfort, or blurred vision

Most reactions are mild to moderate and localized to the eye or, in the case of dysgeusia, related todrainage through the nasolacrimal duct. Patients should contact their physician if any reaction issevere, persistent, or accompanied by signs of a hypersensitivity reaction (e.g., swelling, rash, difficulty breathing).

Pregnancy: There are limited or no adequate, well-controlled human data on the use ofLiftear in pregnant women. Because systemic absorption of Liftear after ocular administration is low, therisk to the fetus is expected to be minimal, but Liftear should be used during pregnancy only if clearlyneeded and if the potential benefit justifies the potential risk to the fetus. Consult a physician beforeuse during pregnancy.

Lactation: It is not known whether Liftear is excreted in human breast milk. Becausemany drugs are excreted in human milk, caution should be exercised when Liftear is used by a breastfeedingwoman, and a physician should be consulted to weigh the benefits of treatment against any potential risk to the infant.

• For topical ophthalmic use only. Liftear is not for injection or oral use.
• Contact lens wear: Remove contact lenses prior to instillation of Liftear; lenses may be reinserted after the waiting period specified in product instructions (see Administration).
• Not a substitute for lubricants: Liftear treats the underlying inflammation of dry eye disease but does not provide the immediate lubricating relief of artificial tears; patients needing immediate comfort should discuss appropriate concurrent use of lubricating drops with their physician.
• Delayed onset of benefit: Full therapeutic effect may take several weeks of consistent twice-daily use; patients should be counseled not to expect immediate relief.
• Hypersensitivity: See Contraindications. Discontinue and seek medical advice if signs of a hypersensitivity reaction occur.

There is no specific information on overdose with Liftear in humans. Ocular overdose is unlikely tocause significant toxicity given the drug's low systemic absorption. If Liftear is accidentally ingested orif excessive instillation causes concerning symptoms, seek immediate medical attention or contact a poisoncontrol center/emergency services rather than attempting home treatment.

Store at room temperature (below 30°C), away from light and moisture. Do not freeze. Keep out of reach of children. Discard any unused single-use vial after opening; do not reuse.

Pediatric Use

The safety and efficacy of Liftear in pediatric patients below 17 years of age have not been established.

Geriatric Use

No overall differences in safety or effectiveness of Liftear have been observed between elderly and younger adult patients; no dose adjustment is required based on age alone.

Renal/Hepatic Impairment

No specific dose adjustment of Liftear is recommended for renal or hepatic impairment, given minimal systemic absorption after topical ocular use.

Pregnancy and Lactation

See Pregnancy and Lactation section above for full details.

Liftear is generally used long-term/chronically for dry eye disease as directed by a physician, since itaddresses an ongoing inflammatory process rather than providing a one-time cure. Full benefit may takeseveral weeks of consistent twice-daily use. Duration should be re-evaluated periodically by theprescribing physician based on clinical response.

LFA-1 (lymphocyte function-associated antigen-1) antagonist; ophthalmic anti-inflammatory agent for dry eye disease — Lifitegrast is the sole member of this class in common ophthalmic use.

Lifitegrast binds to the integrin lymphocyte function-associated antigen-1 (LFA-1), blocking its interactionwith intercellular adhesion molecule-1 (ICAM-1), which is overexpressed on the ocular surface in dry eyedisease. By inhibiting the LFA-1/ICAM-1 interaction, Lifitegrast reduces T-cell activation, adhesion, andmigration to the ocular surface, thereby decreasing the chronic inflammation that drives the signs andsymptoms of dry eye disease.

The safety and efficacy of Liftear have not been established in pediatric patients younger than 17 yearsof age. Liftear is therefore not recommended for use in this age group outside of a physician's specificguidance, as there is insufficient evidence to support routine pediatric use.