line.
Effects on Symptoms of Dry Eye Disease
Eye dryness Score (EDS) was rated by patients using a visual analogue scale (VAS) (0 = no discomfort, 100 = maximal discomfort) at each study visit. The average baseline EDS was between 40 and 70. A larger reduction in EDS favoring Xiidra was observed in all studies at Day 42 and Day 84 (see Figure 1).
Figure 1: Mean Change (SD) from Baseline and Treatment Difference (Xiidra – Vehicle) in Eye Dryness Score in 12-Week Studies in Patients with Dry Eye Disease
[1] Based on ANCOVA model adjusted for baseline value in Study 1, and ANCOVA model adjusted for baseline value and randomization stratification factors in Studies 2-4. All randomized and treated patients were included in the analysis and missing data were imputed using last-available data. In Study 1, one Xiidra treated subject who did not have a baseline value was excluded from analysis.
Effects on Signs of Dry Eye Disease
Inferior fluorescein corneal staining score (ICSS) (0 = no staining, 1 = few/rare punctate lesions, 2 = discrete and countable lesions, 3 = lesions too numerous to count but not coalescent, 4 = coalescent) was recorded at each study visit. The average baseline ICSS was approximately 1.8 in Studies 1 and 2, and 2.4 in Studies 3 and 4. At Day 84, a larger reduction in ICSS favoring Xiidra was observed in three of the four studies (see Figure 2).
Figure 2: Mean Change (SD) from Baseline and Treatment Difference (Xiidra – Vehicle) in Inferior Corneal Staining Score in 12-Week Studies in Patients with Dry Eye Disease.
[1] Based on ANCOVA model adjusted for baseline value in Study 1, and ANCOVA model adjusted for baseline value and randomization stratification factors in Studies 2-4. All randomized and treated patients were included in the analysis and missing data were imputed using last-available data. In Study 2, one Vehicle treated subject who did not have a study eye designated was excluded from analysis.
16 HOW SUPPLIED/STORAGE AND HANDLING
Xiidra (lifitegrast ophthalmic solution) 5% (50 mg/mL) is supplied in a foil pouch containing 5 low density polyethylene 0.2 mL single-use containers.
NDC 54092-606-01; Carton of 60 single-use containers.
Storage:
Store at 20-25°C (68-77°F). Store single-use containers in the original foil pouch.
17 PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling.
Handling the Single-use Container
Advise patients not to touch the tip of the single-use container to their eye or to any surface, in order to avoid eye injury or contamination of the solution.
Use with Contact Lenses
Advise patients that contact lenses, should be removed prior to administration of Xiidra and can be reinserted 15 minutes after administration [see Dosage and Administration (2)].
Administration
Advise patients that the solution from one single-use container is to be used immediately after opening. It can be used to dose both eyes. The single-use container, including any remaining contents should be discarded immediately after administration [see Dosage and Administration (2)].
Storage Information
Instruct patients to store single-use containers in the original foil pouch until ready to use.
Patient Information Xiidra™ (ZYE-druh) (lifitegrast ophthalmic solution) 5%
What is Xiidra?
Xiidra is a prescription eye drop solution used to treat the signs and symptoms of dry eye disease. It is not known if Xiidra is safe and effective in children under 17 years of age.
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