USA Study

Question 1

Intraoperative Surgical Complications N=65

Answer 1

No surgical complications N = 65; 100%

Question 2

Operative parameters

Answer 2

Majority of subjects only 1 injector was used to implant N = 56; 86.2%

Question 3

Operative parameters

Answer 3

Intraoperative stent removal and replacement with 11 devices in order to ensure proper placement N = 9; 13.8%

Question 4

Operative parameters

Answer 4

Stent implanted N = 65; 100%

Question 5

Operative parameters

Answer 5

Superior nasal placement location N = 56; 86.2%

Question 6

Operative parameters

Answer 6

Superior temporal placement location N = 9; 13.8%

Question 7

Subject Accountability

Answer 7

Fifty-four subjects (83.1%) completed the 12-month visit and 49 subjects (75.4%) completed the
18-month visit.

Question 8

Ocular Adverse Events within 12 Months N = 65

Answer 8

Anterior chamber shallow with peripheral irido-corneal touch 1 (1.5%)

Question 9

Ocular Adverse Events within 12 Months N = 65

Answer 9

BCVA loss of >= 2 lines (>= 10 ETDRS letters)
≤ 30 days 10 (15.4%)
> 30 days 7 (10.8%)
At 12 months (persistent loss) 4 (6.2%)

Question 10

Ocular Adverse Events within 12 Months N = 65

Answer 10

Bleb leak (without operative room or slit lamp revision) 1 (1.5%)

Question 11

Ocular Adverse Events within 12 Months N = 65

Answer 11

Choroidal effusion (extending posterior to equator, without blood) 2 (3.1%)

Question 12

Ocular Adverse Events within 12 Months N = 65

Answer 12

Corneal edema grade 3 or grade 4 (> 30 days postoperatively) 1 (1.5%)

Question 13

Ocular Adverse Events within 12 Months N = 65

Answer 13

Dellen 1 (1.5%)

Question 14

Ocular Adverse Events within 12 Months N = 65

Answer 14

Hyphema (>= 2 mm in height (layered) at any time) 3 (4.6%)

Question 15

Ocular Adverse Events within 12 Months N = 65

Answer 15

Hypotony (IOP < 6 mmHg at any time) 16 (24.6%)

Question 16

Ocular Adverse Events within 12 Months N = 65

Answer 16

Implant exposure 1 (1.5%)

Question 17

Ocular Adverse Events within 12 Months N = 65

Answer 17

Implant migration 1 (1.5%)

Question 18

Ocular Adverse Events within 12 Months N = 65

Answer 18

Implant repositioning requiring surgical intervention 1 (1.5%)

Question 19

Ocular Adverse Events within 12 Months N = 65

Answer 19

IOP increase >= 10 mmHg from baseline 14 (21.5%)

Question 20

Ocular Adverse Events within 12 Months N = 65

Answer 20

Macular edema 1 (1.5%)

Question 21

Ocular Adverse Events within 12 Months N = 65

Answer 21

Needling procedure 21 (32.3%)

Question 22

Ocular Adverse Events within 12 Months N = 65

Answer 22

Secondary surgical intervention
Explant 1 (1.5%)

Question 23

Ocular Adverse Events within 12 Months N = 65

Answer 23

Secondary surgical intervention

Secondary glaucoma procedure with explant 6 (9.2%)

Question 24

Ocular Adverse Events within 12 Months N = 65

Answer 24

Secondary surgical intervention

Secondary glaucoma procedure 2 (3.1%)

Question 25

Ocular Adverse Events within 12 Months N = 65

Answer 25

Significant (2-grade) worsening or a grade of moderate or severe, for any slit lamp observation for which a standard grading scale is not available (> 30 days postoperatively) Anterior chamber cells 2 (3.1%)

Question 26

Ocular Adverse Events within 12 Months N = 65

Answer 26

``` Significant (2-grade) worsening or a grade of moderate or severe, for any slit lamp observation for which a standard grading scale is not available (> 30 days postoperatively) Blepharitis 1 (1.5%) ```

Question 27

Ocular Adverse Events within 12 Months N = 65

Answer 27

Significant (2-grade) worsening or a grade of moderate or severe, for any slit lamp observation for which a standard grading scale is not available (> 30 days postoperatively) Dysesthetic bleb 1 (1.5%)

Question 28

Ocular Adverse Events within 12 Months N = 65

Answer 28

``` Significant (2-grade) worsening or a grade of moderate or severe, for any slit lamp observation for which a standard grading scale is not available (> 30 days postoperatively) Chalazion 1 (1.5%) ```

Question 29

Ocular Adverse Events within 12 Months N = 65

Answer 29

``` Significant (2-grade) worsening or a grade of moderate or severe, for any slit lamp observation for which a standard grading scale is not available (> 30 days postoperatively) Hyperemia 1 (1.5%) ```

Question 30

Ocular Adverse Events within 12 Months N = 65

Answer 30

Significant (2-grade) worsening or a grade of moderate or severe, for any slit lamp observation for which a standard grading scale is not available (> 30 days postoperatively) Wound leak/dehiscence 6 (9.2%)

Question 31

Ocular Adverse Events within 12 Months N = 65

Answer 31

Anterior chamber fill 1 (1.5%)

Question 32

Ocular Adverse Events within 12 Months N = 65

Answer 32

Anterior chamber tap 6 (9.2%)

Question 33

Ocular Adverse Events within 12 Months N = 65

Answer 33

Fixed dilated pupil 1 (1.5%)

Question 34

Ocular Adverse Events within 12 Months N = 65

Answer 34

Macular puckering 1 (1.5%)

Question 35

Ocular Adverse Events within 12 Months N = 65

Answer 35

Vitreous loss 1 (1.5%)

Question 36

Ocular Adverse Events within 12 Months N = 65

Answer 36

Wound repair 5 (7.7%)

Question 37

Ocular Adverse Events within 12 Months N = 65

Answer 37

YAG capsulotomy 3 (4.6%)

Question 38

Bleb Needling Procedure at <= 12 Months XEN Implanted Subjects Bleb Needling Performed

Answer 38

``` Yes 21 (32.3%) No 44 (67.7%) ```

Question 39

Bleb Needling Procedure at <= 12 Months XEN Implanted Subjects Reason for Bleb Needling

Answer 39

Flat bleb with absence of microcysts 11 (16.9%) Bleb filtration area is fibrotic or blocked 12 (18.5%) Subject has a high risk of bleb failure based on assessment by the investigator 10 (15.4%)

Question 40

Bleb Needling Procedure at <= 12 Months XEN Implanted Subjects Number of Needling Procedures Performed per subject

Answer 40

1 time 14 (21.5%) 2 time 6 (9.2%) 3 time 1 (1.5%)

Question 41

Bleb Needling Procedure at <= 12 Months XEN Implanted Subjects # of Subjects who had Needling Procedure with MMC

Answer 41

``` No 14 (21.5%) Yes 7 (10.8%) ```