Approval Status: Approved July 2016
Specific Treatments: dry eye disease
Therapeutic Areas Ophthalmology
Xiidra (lifitegrast) is an orally active dual leukocyte function-associated antigen-1 (LFA-1)/intracellular adhesion molecule-1(ICAM-1) inhibitor. LFA-1 antagonists mediate both migration and adhesion of the white blood cells to sites of inflammation.
Xiidra is specifically indicated for the treatment of the signs and symptoms of dry eye disease.
Xiidra is supplied as an ophthalmic solution for topical ophthalmic use. The recommended dose is one drop twice daily in each eye (approximately 12 hours apart).
The FDA approval of Xiidra was based on four 12-week, randomized, multi-center, double-masked, vehicle-controlled studies in a total of 1,181 patients. Patients were randomized to Xiidra or vehicle (placebo) in a 1:1 ratio and dosed twice a day. Use of artificial tears was not allowed during the studies. Eye dryness Score (EDS) was rated by patients using a visual analogue scale (VAS) (0 = no discomfort, 100 = maximal discomfort) at each study visit. Assessment of signs was based on inferior corneal staining score (ICSS; 0-4 scale). In all four studies, a larger reduction in EDS was observed with Xiidra at six and 12 weeks. In two of the four studies, an improvement in EDS was seen with Xiidra at two weeks. At week 12, a larger reduction in ICSS favoring Xiidra was observed in three of the four studies.
Adverse effects associated with the use of Xiidra may include, but are not limited to, the following:
- instillation site irritation
- decreased visual acuity
Mechanism of Action
Xiidra (lifitegrast) is an orally active dual leukocyte function-associated antigen-1 (LFA-1)/intracellular adhesion molecule-1(ICAM-1) inhibitor. LFA-1 is 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 dry eye disease. LFA-1/ICAM-1 interaction can contribute to the formation of an immunological synapse resulting in T-cell activation and migration to target tissues.
For additional information regarding Xiidra or dry eye disease, please visit https://www.xiidra.com/