Clinical Overview: Lifitegrast Ophthalmic Solution (Xiidra) for Dry Eye Disease


In clinical trials, Xiidra was found to improve eye dryness scores significantly compared with placebo.

Lifitegrast ophthalmic solution (Xiidra) is a lymphocyte function-associated antigen-1 (LFA-1) antagonist indicated for the treatment of symptoms associated with dry eye disease (DED) in adults.1 The FDA approved lifitegrast in July 2016.

In a clinical trial, researchers randomized 811 participants with DED to receive either lifitegrast or a placebo in a 1:1 ratio to measure the reduction in eye dryness score (EDS). The EDS ranges from 0 to 100, with 0 being no discomfort and 100 being maximum discomfort.

All participants had an EDS of 40 or higher. The researchers monitored changes in EDS at days 14, 42, and 84 with lifitegrast 5%, and the study was powered to measure reductions in EDS by 6.5, 8.0, and 10.0 units, respectively.2

Lifitegrast improved EDS significantly compared with placebo, with participants reporting improvement as soon as day 14. Patients treated with lifitegrast also noted greater improvements in itching, foreign body sensation, and eye discomfort than those in the placebo group.2

Mechanism of Action

Lifitegrast binds to the integrin LFA-1 protein and blocks the interaction with its cognate ligand intracellular adhesion molecule-1 (ICAM-1). The exact mechanism of action in DED is unknown, but is suspected to be inhibition of inflammatory cytokine release from reduced T-cell adhesion to ICAM-1.1

Dosage and Administration

Lifitegrast 5% ophthalmic single use container: Instill 1 drop into each eye twice daily.

Counseling Points1

  • Pharmacists should counsel patients who use contacts to remove them prior to administration and leave them out for at least 15 minutes.
  • Pharmacists should counsel patients on proper technique for instilling eye drops. This should include the key points of washing their hands before and after administration and not touching the tip of the container.
  • Pharmacists should counsel patients that each container is single-use and should be discarded after instilling a drop in each eye.
  • Pharmacists should counsel patients on the possibility of dysgeusia as an adverse event (AE) to limit patient concern should it occur.
  • Patients should store lifitegrast 5% containers in their original foil packaging at room temperature.


The most common AEs reported were dysgeusia, instillation-site irritation, and decreased visual acuity.1

Warnings and Precautions

Cases of patients experiencing hypersensitivity to lifitegrast were seen in post market reports.

Pregnancy and Lactation1

  • Data regarding the use of lifitegrast 5% ophthalmic solution in pregnancy are lacking. Animal models using IV lifitegrast at 400-fold to 460-fold the human plasma exposure level found no evidence of a teratogenic effect. Patients should discuss any risk with their provider.
  • There are no data on the presence of lifitegrast in breastmilk, but the systemic exposure from ocular administration is low. The benefits of breastfeeding should be considered along with the mother’s clinical need for this medication and the potential AEs on the child.

About the Author

Matthew Gall is a 2024 PharmD candidate at the University of Connecticut.


1. Xiidra Prescribing Information. July 2016. Accessed May 8, 2022

2. Holland EJ, Luchs J, Karpecki PM, et al. Lifitegrast for the treatment of dry eye disease: results of a phase iii, randomized, double-masked, placebo-controlled trial (OPUS-3). Ophthalmology. 2017;124(1):53-60. doi:10.1016/j.ophtha.2016.09.025 Accessed May 8, 2022

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