XIIDRA® IMPROVED THE SIGNS OF DRY EYE DISEASE

In 3 of the 4 studies, a larger reduction in Inferior Corneal Staining Score (ICSS) favouring XIIDRA® over the vehicle was observed at 12 weeks.1

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 signs was based on change from baseline in ICSS. ICSS was measured on a scale of 0 to 4 in increments of 0.5.

Inferior 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

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

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

STUDY 1 (Phase II)

Mean Change From Baseline in ICSS
VISIT VEHICLE
(N = 58) 		XIIDRA®
(N = 58) 		DIFFERENCE
(95% CI*)
Baseline 1.65 1.77
Week 2 0.24 0.06 -0.14 (-0.36, 0.08)
Week 6 0.19 0.08 -0.05 (-0.28, 0.17)
Week 12 0.38 0.04 -0.25 (-0.50, -0.00)

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

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

Adapted from Semba et al. 2012

STUDY 2 (OPUS-1)

Mean Change From Baseline in ICSS
VISIT VEHICLE
(N = 295) 		XIIDRA®
(N = 293) 		DIFFERENCE
(95% CI*)
Baseline  1.81  1.84
Week 2  0.08  0.04 -0.03 (-0.14, 0.08)
Week 6 -0.02 -0.14 -0.10 (-0.23, 0.02)
Week 12  0.17 -0.07 -0.23 (-0.36, – 0.10)

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

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

Adapted from Sheppard et al. 2014

In study 2, statistically significant improvement in the symptom co-primary endpoint (change in visual function subscale of Ocular Surface Disease Index) was not demonstrated.

STUDY 4 (OPUS-3)

Mean Change From Baseline in ICSS
VISIT VEHICLE
(N = 356) 		XIIDRA®
(N = 355) 		DIFFERENCE
(95% CI*)
Baseline  2.46  2.46
Week 2 -0.44 -0.49 -0.05 (-0.17, 0.07)
Week 6 -0.66 -0.69 -0.03 (-0.16, – 0.10)
Week 12 -0.63 -0.80 -0.17 (-0.30, – 0.03)

Study 4 (N = 711): change in ICSS from baseline to week 12.

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

Adapted from Holland et al. 2017

STUDY 3 (OPUS-2)

Mean Change From Baseline in ICSS
VISIT VEHICLE
(N = 360) 		XIIDRA®
(N = 358) 		DIFFERENCE
(95% CI*)
Baseline 2.40 2.39
Week 2 -0.48 -0.48 -0.00 (-0.11, 0.11)
Week 6 -0.60 -0.69 -0.09 (-0.22, 0.04)
Week 12 -0.71 -0.73 -0.03 (-0.16, 0.10)

Study 3 (N = 718): change in ICSS from baseline to week 12.

* Confidence Interval

Reference:

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

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