XIIDRA® IMPROVED THE SYMPTOMS OF DRY EYE DISEASE IN AS EARLY AS 2 WEEKS1

In 2 of 4 studies, a statistically significant treatment difference favouring XIIDRA® vs. vehicle was seen in as early as 2 weeks in some patients, and also at 6 and 12 weeks as measured by eye dryness score (EDS).

STUDY DESIGN

The safety profile and efficacy of XIIDRA® vs. vehicle were studied in 2247 subjects diagnosed with Dry Eye Disease in four randomized, double-masked, 12-week trials.1

Each of the four studies assessed the effect of XIIDRA® vs. vehicle on both the signs and symptoms of Dry Eye Disease at baseline and weeks 2, 6, and 12.

Assessment of symptoms was based on change from baseline in patient-reported Eye Dryness Score. Patients reported their symptoms on a scale from 0 to 100.

In studies 1 and 2, a controlled adverse environment model was used during the screening period to identify subjects who were more susceptible to environmental stressors.

In studies 3 and 4, patients were required to have a history of recent artificial tear use.

In all four studies, use of artificial tears was prohibited during the 12-week period.

STUDY 3 (OPUS-2)

Mean Change From Baseline in EDS
VISIT VEHICLE
(N = 360) 		XIIDRA®
(N = 358) 		DIFFERENCE
(95% CI*)
Baseline 69.2 69.7
Week 2 -13.1 -19.7 -6.4 (-10.0, -2.8)
Week 6 -18.2 -28.3 -10.0 (-13.8, -6.1)
Week 12 -22.8 -35.3 -12.3 (-16.4, -8.3)

Study 3 (N = 718), change in EDS from baseline to week 12.

ITT, intent to treat; LOCF, last observation carried forward

Adapted from Tauber et al. 2015

In study 3, statistically significant improvement in the other co-primary endpoint (change in ICSS* from baseline to week 12) was not observed.

*ICSS = Inferior Corneal Staining Score

STUDY 4 (OPUS-3)

Mean Change From Baseline in EDS
VISIT VEHICLE
(N = 356) 		XIIDRA®
(N = 355) 		DIFFERENCE
(95% CI*)
Baseline 69.0 68.3
Week 2 -14.9 -22.7 -8.0 (-11.4, -4.5)
Week 6 -23.7 -33.0 -9.6 (-13.4, -5.8)
Week 12 -30.5 -37.7 -7.5 (-11.6, -3.5)

Study 4 (N = 711), change in EDS from baseline to week 12.

ITT, intent to treat; LOCF, last observation carried forward

Adapted from Holland et al. 2017

STUDY 1 (Phase II)

Mean Change From Baseline in EDS
VISIT VEHICLE
(N = 58) 		XIIDRA®
(N = 58) 		DIFFERENCE
(95% CI*)
Baseline 51.8 51.6
Week 2 -3.9 -8.9 -5.1 (-13.1, 3.0)
Week 6 -7.9 -17.3 -9.4 (-17.0, -1.9)
Week 12 -7.2 -14.4 -7.3 (-16.1, 1.4)

Study 1 (N = 230), change in EDS from baseline to week 12.

STUDY 2 (OPUS-1)

Mean Change From Baseline in EDS
VISIT VEHICLE
(N = 295) 		XIIDRA®
(N = 293) 		DIFFERENCE
(95% CI*)
Baseline 41.6 40.2
Week 2 –7.5 –6.7  0.1 (-3.9, 4.1)
Week 6 –9.1 –12.6 -4.2 (-8.5, 0.0)
Week 12 –11.2 –15.2 -4.7 (-8.9, -0.4)

Study 2 (N = 588), change in EDS from baseline to week 12.

* Confidence Interval

Reference :

1. XIIDRA® Product Monograph. Novartis Pharmaceuticals Canada Inc. February 13, 2020.

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