Lifitegrast

XIIDRA

What it isLFA-1 antagonist blocking T-cell mediated inflammation; dry eye disease.

Why this oneIt targets the inflammation rather than only lubricating, and it works faster than cyclosporine drops.

What limits itAn intense unpleasant taste immediately after instillation is the usual reason for stopping.

FDA-approved for

FDA dosing	Population	Start	Target	Max
Dry eye disease	Adults	1 drop in each eye BID (~12h apart)	1 drop each eye BID	1 drop each eye BID

Renal Undefined

Hepatic Undefined

Instill one drop into each eye twice daily (~12 hours apart) using a single-use container; discard immediately after using in each eye.
Remove contact lenses before administration; may reinsert 15 minutes afterward.

Hypersensitivity reactions incl. anaphylaxis, bronchospasm, respiratory distress, angioedema (postmarketing)

Instillation-site irritation
Dysgeusia (altered taste)
Reduced/blurred visual acuity
Eye irritation/discomfort, conjunctival hyperemia, increased lacrimation, headache

Pregnancy No human data; low systemic exposure after ocular use; animal omphalocele at high IV doses of unclear relevance.

Lactation No data on presence in human milk; systemic exposure from ocular use is low.

NO BOXED WARNINGS

Principal riskDysgeusia immediately after instillation

Cost, est. cash$200–$1,000/month

Generic entry2023

Therapeutic safety burden0 / 4

Overdose danger0 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk0 / 4

Legacy pregnancy categoryNot assigned — PLLR-era drug

Defining liabilityLocal irritation, sensitization or administration-site injury; negligible systemic toxicity at usual use.