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Xiidra (LIFITEGRAST)

Xiidra works by blocking the interaction between immune cells and the surface of the eye, reducing inflammation and promoting tear production.

Xiidra (Lifitegrast) is a small molecule lymphocyte function-associated antigen-1 (LFA-1) antagonist developed by Shire DEV LLC and currently owned by Bausch and Lomb Inc. It targets intercellular adhesion molecule 1 (ICAM-1) to treat tear film insufficiency. Xiidra was FDA-approved in 2016 and is available in both patented and generic forms. As a LFA-1 antagonist, Xiidra works by blocking the interaction between LFA-1 and ICAM-1, which plays a crucial role in the inflammatory response. It is used to treat dry eye disease.

At a glance

Mechanism of action

Lifitegrast binds to the integrin LFA-1, 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 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.

Approved indications

• Tear film insufficiency

Common side effects

• instillation-site irritation
• dysgeusia
• decreased visual acuity
• blurred vision
• conjunctival hyperemia
• eye irritation
• headache
• increased lacrimation
• eye discharge
• eye discomfort
• eye pruritus
• sinusitis

Key clinical trials

• This is a Single Center, Open-label Prospective Study to Evaluate the Effect of Xiidra® (Lifitegrast Ophthalmic Solution 5.0%) on Tear Film Biomarkers in Dry Eye (PHASE4)
• A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease (PHASE2)
• Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications
• A Study to Assess the Long-Term Safety of Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination in Subjects With Dry Eye Disease (PHASE3)
• Switching From Xiidra to TRYPTYR (PHASE4)
• A Study to Explore Signs, Symptoms, and Biomarkers in Dry Eye Disease Participants Following Anti-inflammatory Treatment (PHASE4)
• Lifitegrast Eye Drops in Healthy Subjects：Phase I Study (PHASE1)
• A Study of the Drugs AGN-242428 and AGN-231868 in Participants With Dry Eye Disease (PHASE1,PHASE2)

Patents

Primary sources

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