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.