Trial Outcomes & Findings for XEN-45 Gel Stent Versus Trabeculectomy in Glaucoma: Gold-Standard Pathway Study (GPS) (NCT NCT03654885)

NCT ID: NCT03654885

Last Updated: 2022-07-21

Results Overview

IOP is a measure of the fluid pressure inside the eye. In addition to achieving a 20% reduction of IOP from Baseline, the participants had to meet all of the following prespecified caveats at Month 12: no increase in the number of topical IOP-lowering medications compared to Baseline, no clinical hypotony, no loss of vision to count fingers or worse, and no secondary glaucoma surgical intervention.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 158 participants
• Primary outcome timeframe: Baseline (Preoperative) to Month 12
• Results posted on: 2022-07-21

Participant Flow

One eye, the worse eye, from each participant was selected as the study eye. The worse eye was defined using the visual field mean deviation (MD) at baseline, with the worse eye having the most negative MD. In the case where the MD was the same in both eyes, to two decimal places, the worse eye is defined as the eye with the higher IOP.

Unit of analysis: eyes

Participant milestones

Measure	XEN-45 Gel Stent Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Overall Study STARTED	107 107	51 51
Overall Study Intent-to-Treat (ITT) Population	95 95	44 44
Overall Study Safety Population	95 95	44 44
Overall Study COMPLETED	77 77	38 38
Overall Study NOT COMPLETED	30 30	13 13

Reasons for withdrawal

Measure	XEN-45 Gel Stent Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Overall Study Randomized, Not Treated: Consent Withdrawn	5	3
Overall Study Randomized, Not Treated: Investigators Decision (Unrelated to Adverse Event [AE])	0	3
Overall Study Randomized, Not Treated: Study on-hold due to Device Recall	7	1
Overall Study Additional Glaucoma Surgery (Secondary Surgical Intervention [SSI])	7	1
Overall Study Additional Ophthalmic Surgery (Not for Intraocular pressure [IOP] Control)	1	0
Overall Study Adverse Event in Study Eye	3	0
Overall Study Consent Withdrawn	1	0
Overall Study Death	3	1
Overall Study Did Not Meet Inclusion Criteria (IC) Diagnosis of Ocular Hypertension (Dx OHT)	0	1
Overall Study Lost to Follow-up	3	3

Baseline Characteristics

Ethnicity data was not collected

Baseline characteristics by cohort

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).	Total n=139 Participants Total of all reporting groups
Age, Continuous	69.5 years STANDARD_DEVIATION 9.64 • n=95 Participants	69.4 years STANDARD_DEVIATION 9.72 • n=44 Participants	69.5 years STANDARD_DEVIATION 9.63 • n=139 Participants
Sex: Female, Male Female	41 Participants n=95 Participants	19 Participants n=44 Participants	60 Participants n=139 Participants
Sex: Female, Male Male	54 Participants n=95 Participants	25 Participants n=44 Participants	79 Participants n=139 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	18 Participants n=95 Participants	10 Participants n=44 Participants	28 Participants n=139 Participants
Race/Ethnicity, Customized Asian	2 Participants n=95 Participants	0 Participants n=44 Participants	2 Participants n=139 Participants
Race/Ethnicity, Customized Black or African American	14 Participants n=95 Participants	8 Participants n=44 Participants	22 Participants n=139 Participants
Race/Ethnicity, Customized White or Caucasian	61 Participants n=95 Participants	26 Participants n=44 Participants	87 Participants n=139 Participants
Race/Ethnicity, Customized Ethnicity	—	—	0 Participants Ethnicity data was not collected
Study Eye Intraocular Pressure (IOP)	23.13 millimetre of mercury (mm Hg) STANDARD_DEVIATION 5.817 • n=95 Participants	22.56 millimetre of mercury (mm Hg) STANDARD_DEVIATION 5.653 • n=44 Participants	22.95 millimetre of mercury (mm Hg) STANDARD_DEVIATION 5.751 • n=139 Participants

PRIMARY outcome

Timeframe: Baseline (Preoperative) to Month 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery.

IOP is a measure of the fluid pressure inside the eye. In addition to achieving a 20% reduction of IOP from Baseline, the participants had to meet all of the following prespecified caveats at Month 12: no increase in the number of topical IOP-lowering medications compared to Baseline, no clinical hypotony, no loss of vision to count fingers or worse, and no secondary glaucoma surgical intervention.

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Participants Achieving at Least 20% Intraocular Pressure (IOP) Reduction (Improvement) From Baseline at Month 12 With Prespecified Caveats	62.1 percentage of participants	68.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Number analyzed is the number of participants with data available for analysis at the specified timepoints.

IOP is a measurement of the fluid pressure inside the eye.

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Mean IOP Over Time Month 6	14.86 mm Hg Standard Deviation 4.228	11.72 mm Hg Standard Deviation 5.242
Mean IOP Over Time Day 1	9.25 mm Hg Standard Deviation 4.710	15.00 mm Hg Standard Deviation 13.025
Mean IOP Over Time Week 1	11.27 mm Hg Standard Deviation 6.864	11.48 mm Hg Standard Deviation 7.323
Mean IOP Over Time Week 2	13.64 mm Hg Standard Deviation 8.363	11.53 mm Hg Standard Deviation 5.503
Mean IOP Over Time Month 1	13.72 mm Hg Standard Deviation 6.315	11.45 mm Hg Standard Deviation 5.645
Mean IOP Over Time Month 3	16.46 mm Hg Standard Deviation 7.407	11.59 mm Hg Standard Deviation 4.672
Mean IOP Over Time Month 9	14.57 mm Hg Standard Deviation 4.221	11.02 mm Hg Standard Deviation 3.535
Mean IOP Over Time Month 12	14.43 mm Hg Standard Deviation 4.060	11.83 mm Hg Standard Deviation 3.525

SECONDARY outcome

Timeframe: Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Number analyzed is the number of participants with data available for analysis at the specified timepoints.

IOP is a measurement of the fluid pressure inside the eye.

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Change From Baseline in Mean IOP Over Time Change From Baseline at Day 1	-13.63 mm Hg Standard Error 0.645	-7.82 mm Hg Standard Error 0.958
Change From Baseline in Mean IOP Over Time Change From Baseline at Week 1	-11.56 mm Hg Standard Error 0.660	-11.34 mm Hg Standard Error 0.958
Change From Baseline in Mean IOP Over Time Change From Baseline at Week 2	-9.26 mm Hg Standard Error 0.657	-11.29 mm Hg Standard Error 0.958
Change From Baseline in Mean IOP Over Time Change From Baseline at Month 1	-9.15 mm Hg Standard Error 0.648	-11.37 mm Hg Standard Error 0.958
Change From Baseline in Mean IOP Over Time Change From Baseline at Month 3	-6.35 mm Hg Standard Error 0.663	-11.09 mm Hg Standard Error 0.977
Change From Baseline in Mean IOP Over Time Change From Baseline at Month 6	-7.94 mm Hg Standard Error 0.690	-10.95 mm Hg Standard Error 0.978
Change From Baseline in Mean IOP Over Time Change From Baseline at Month 9	-8.19 mm Hg Standard Error 0.690	-11.72 mm Hg Standard Error 0.978
Change From Baseline in Mean IOP Over Time Change From Baseline at Month 12	-8.25 mm Hg Standard Error 0.701	-11.02 mm Hg Standard Error 1.009

SECONDARY outcome

Timeframe: Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Number analyzed is the number of participants with data available for analysis at the specified timepoints.

IOP is a measurement of the fluid pressure inside the eye. Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors,alpha adrenergic agonists, pilocarpine, and combinations of these treatments.

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Mean Number of Topical IOP-Lowering Medications Over Time Day 1	0.2 medications Standard Deviation 0.51	0.3 medications Standard Deviation 0.53
Mean Number of Topical IOP-Lowering Medications Over Time Week 1	0.3 medications Standard Deviation 0.77	0.3 medications Standard Deviation 0.73
Mean Number of Topical IOP-Lowering Medications Over Time Week 2	0.3 medications Standard Deviation 0.64	0.2 medications Standard Deviation 0.53
Mean Number of Topical IOP-Lowering Medications Over Time Month 1	0.3 medications Standard Deviation 0.75	0.1 medications Standard Deviation 0.52
Mean Number of Topical IOP-Lowering Medications Over Time Month 3	0.5 medications Standard Deviation 0.89	0.1 medications Standard Deviation 0.26
Mean Number of Topical IOP-Lowering Medications Over Time Month 6	0.6 medications Standard Deviation 0.96	0.2 medications Standard Deviation 0.58
Mean Number of Topical IOP-Lowering Medications Over Time Month 9	0.6 medications Standard Deviation 1.09	0.2 medications Standard Deviation 0.49
Mean Number of Topical IOP-Lowering Medications Over Time Month 12	0.6 medications Standard Deviation 0.95	0.3 medications Standard Deviation 0.50

SECONDARY outcome

Timeframe: Baseline and Day 1, Weeks 1 and 2, Months 1, 3, 6, 9, and 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Number analyzed is the number of participants with data available for analysis at the specified timepoints.

IOP is a measurement of the fluid pressure inside the eye. Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors,alpha adrenergic agonists, pilocarpine, and combinations of these treatments.

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time Change From Baseline at Day 1	-2.1 medications Standard Error 0.08	-2.0 medications Standard Error 0.11
Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time Change From Baseline at Week 1	-2.0 medications Standard Error 0.08	-2.0 medications Standard Error 0.11
Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time Change From Baseline at Week 2	-2.0 medications Standard Error 0.08	-2.1 medications Standard Error 0.11
Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time Change From Baseline at Month 1	-2.0 medications Standard Error 0.08	-2.1 medications Standard Error 0.11
Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time Change From Baseline at Month 3	-1.8 medications Standard Error 0.08	-2.2 medications Standard Error 0.11
Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time Change From Baseline at Month 6	-1.7 medications Standard Error 0.08	-2.0 medications Standard Error 0.11
Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time Change From Baseline at Month 9	-1.7 medications Standard Error 0.08	-2.0 medications Standard Error 0.11
Change From Baseline in Mean Number of Topical IOP-Lowering Medications Over Time Change From Baseline at Month 12	-1.7 medications Standard Error 0.08	-2.0 medications Standard Error 0.11

SECONDARY outcome

Timeframe: Baseline (Preoperative) and Month 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery Overall number analyzed are the number of participants with data available for analyses.

IOP is a measurement of the fluid pressure inside the eye.

Outcome measures

Measure	XEN-45 Gel Stent n=78 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=38 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Change From Baseline in Mean IOP at Month 12	-8.25 mm Hg Standard Error 0.701	-11.02 mm Hg Standard Error 1.009

SECONDARY outcome

Timeframe: Baseline (Preoperative) and Month 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall number analyzed are the number of participants with data available for analyses.

IOP is a measurement of the fluid pressure inside the eye. Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments.

Outcome measures

Measure	XEN-45 Gel Stent n=87 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=41 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Change From Baseline in Mean Number of Topical IOP-Lowering Medications at Month 12	-1.7 medications Standard Error 0.08	-2.0 medications Standard Error 0.11

SECONDARY outcome

Timeframe: Baseline (Preoperative) and Month 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall number analyzed are the number of participants with Baseline IOP ≤18 mmHg in the ITT population and data available for analyses.

IOP is a measurement of the fluid pressure inside the eye.

Outcome measures

Measure	XEN-45 Gel Stent n=18 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=9 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Change in Mean IOP From Preoperative Baseline Over Time in Participants With Eyes With Baseline IOP ≤18 mm Hg	-2.83 mm Hg Standard Error 1.281	-4.61 mm Hg Standard Error 1.801

SECONDARY outcome

Timeframe: Baseline (Preoperative) and Month 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall number analyzed are the number of participants with Baseline IOP ≤18 mmHg in the ITT population and data available for analyses.

Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments.

Outcome measures

Measure	XEN-45 Gel Stent n=20 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=11 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Change in Number of Topical IOP-Lowering Medications From Preoperative Baseline to Month 12 in Participants With Eyes With Baseline IOP ≤18 mm Hg	-1.8 medications Standard Error 0.15	-2.1 medications Standard Error 0.20

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery.

IOP is a measurement of the fluid pressure inside the eye. Specific IOP targets included following IOP values (in mm Hg): ≤18, ≤17, ≤16, ≤15, ≤14, ≤13, ≤12 mm Hg.

Outcome measures

Measure	XEN-45 Gel Stent n=95 eyes Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 eyes Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Participants Achieving Specific IOP Targets at Month 12 IOP Value of ≤18 mm Hg	68.4 percentage of participants	84.1 percentage of participants
Percentage of Participants Achieving Specific IOP Targets at Month 12 IOP Value of ≤17 mm Hg	64.2 percentage of participants	79.5 percentage of participants
Percentage of Participants Achieving Specific IOP Targets at Month 12 IOP Value of ≤16 mm Hg	62.1 percentage of participants	79.5 percentage of participants
Percentage of Participants Achieving Specific IOP Targets at Month 12 IOP Value of ≤15 mm Hg	55.8 percentage of participants	72.7 percentage of participants
Percentage of Participants Achieving Specific IOP Targets at Month 12 IOP Value of ≤14 mm Hg	50.5 percentage of participants	63.6 percentage of participants
Percentage of Participants Achieving Specific IOP Targets at Month 12 IOP Value of ≤13 mm Hg	36.8 percentage of participants	56.8 percentage of participants
Percentage of Participants Achieving Specific IOP Targets at Month 12 IOP Value of ≤12 mm Hg	30.5 percentage of participants	43.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Preoperative) to Month 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery.

IOP is a measurement of fluid pressure inside the eye. Specific percentage IOP lower targets included ≥25%, ≥30%, ≥35%, ≥40% ≥45%, and ≥50% IOP reduction.

Outcome measures

Measure	XEN-45 Gel Stent n=95 eyes Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 eyes Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 ≥25% IOP Reduction	60.0 percentage of participants	63.6 percentage of participants
Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 ≥30% IOP Reduction	48.4 percentage of participants	61.4 percentage of participants
Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 ≥35% IOP Reduction	41.1 percentage of participants	61.4 percentage of participants
Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 ≥40% IOP Reduction	35.8 percentage of participants	54.5 percentage of participants
Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 ≥45% IOP Reduction	25.3 percentage of participants	43.2 percentage of participants
Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 ≥50% IOP Reduction	22.1 percentage of participants	43.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Preoperative) and Month 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery.

IOP is a measurement of fluid pressure inside the eye. Specific IOP targets included following IOP values (in mm Hg): ≤18, ≤17, ≤16, ≤15, ≤14, ≤13, ≤12 mm Hg.

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Participants Achieving at Least a 20% IOP Reduction and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12 IOP Target ≤18 mm Hg	61.1 percentage of participants	72.7 percentage of participants
Percentage of Participants Achieving at Least a 20% IOP Reduction and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12 IOP Target ≤17 mm Hg	58.9 percentage of participants	70.5 percentage of participants
Percentage of Participants Achieving at Least a 20% IOP Reduction and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12 IOP Target ≤16 mm Hg	56.8 percentage of participants	70.5 percentage of participants
Percentage of Participants Achieving at Least a 20% IOP Reduction and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12 IOP Target ≤15 mm Hg	55.8 percentage of participants	70.5 percentage of participants
Percentage of Participants Achieving at Least a 20% IOP Reduction and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12 IOP Target ≤14 mm Hg	50.5 percentage of participants	61.4 percentage of participants
Percentage of Participants Achieving at Least a 20% IOP Reduction and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12 IOP Target ≤13 mm Hg	36.8 percentage of participants	54.5 percentage of participants
Percentage of Participants Achieving at Least a 20% IOP Reduction and Specific IOP Targets on Same or Lower Number of Topical IOP-Lowering Medications at Month 12 IOP Target ≤12 mm Hg	30.5 percentage of participants	43.2 percentage of participants

SECONDARY outcome

Timeframe: Up to Month 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery.

Needling of eye involves breaking down the wall of the scar using a fine needle to improve the drainage of fluid inside the eye.

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Participants With Needlings Performed	23.2 percentage of participants	18.2 percentage of participants

SECONDARY outcome

Timeframe: Up to Month 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall number analyzed are the number of participants who had needlings with evaluable assessment at a specific timepoint.

Needling of eye involves breaking down the wall of the scar using a fine needle to improve the drainage of fluid inside the eye.

Outcome measures

Measure	XEN-45 Gel Stent n=22 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=8 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Mean Number of Needlings Per Eye	1.7 needlings Standard Deviation 1.03	1.4 needlings Standard Deviation 0.74

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall number analyzed are the number of participants who had needlings with evaluable assessment.

IOP is a measurement of fluid pressure inside the eye. Topical IOP-lowering medication classes include: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments.

Outcome measures

Measure	XEN-45 Gel Stent n=16 Eyes Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=7 Eyes Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Eyes Achieving at Least a 20% Reduction in IOP at Month 12 on the Same or Fewer Topical IOP-lowering Medications in Participants Who Had Needlings	87.5 percentage of eyes	85.7 percentage of eyes

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall number analyzed are the number of participants who had needlings with evaluable assessment.

Topical IOP-lowering medication classes included: prostaglandin analogues, beta adrenergic antagonists, carbonic anhydrase inhibitors, alpha adrenergic agonists, pilocarpine, and combinations of these treatments.

Outcome measures

Measure	XEN-45 Gel Stent n=21 Eyes Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=8 Eyes Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Eyes Not Using Any Topical IOP-lowering Medications in Participants Who Had Needlings	42.9 percentage of eyes	75.0 percentage of eyes

SECONDARY outcome

Timeframe: Up to Month 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery.

Antifibrotic use included mitomycin-C (MMC) which was standardized for both groups and administered according to physician training and practice.

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Participants With Antifibrotic Use During Needling	16.8 percentage of participants	15.9 percentage of participants

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. This outcome measure was analyzed among the participants without topical medication at Baseline Qualifying Visit. Number analyzed is the number of participants with data available for analysis at specific timepoint.

Complete success was defined as IOP ≤18mm Hg, with 20% or greater IOP lowering from medicated Baseline, on no topical medications, and no clinical hypotony. The topical medication included any topical ophthalmic medication used on the study eye regardless of the indication and dosage.

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Participants Achieving Complete Success at Month 12	44.2 percentage of participants	59.1 percentage of participants

SECONDARY outcome

Timeframe: Month12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. This outcome measure was analyzed among the participants with topical medication at Baseline Qualifying Visit. Number analyzed is the number of participants with data available for analysis at specific timepoint.

Qualified success was defined as IOP ≤18 mm Hg, with 20% or greater IOP lowering from medicated Baseline, taking topical medications at Baseline Qualifying Visit, no clinical hypotony. The topical medication included any topical ophthalmic medication used on the study eye regardless of the indication and dosage.

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Participants Achieving Qualified Success at Month 12	62.1 percentage of participants	72.7 percentage of participants

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall number analyzed are the number of participants who were medication free at Month 12 with evaluable assessment.

IOP is a measurement of the fluid pressure inside the eye. Specific IOP targets included following IOP values (in mm Hg): ≤18, ≤17, ≤16, ≤15, ≤14, ≤13, ≤12 mm Hg. Medication-free eye at Month 12 was defined as no IOP-lowering medication was used to the study eye at Month 12.

Outcome measures

Measure	XEN-45 Gel Stent n=59 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=31 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye IOP Target ≤18 mm Hg	79.7 percentage of participants	87.1 percentage of participants
Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye IOP Target ≤17 mm Hg	74.6 percentage of participants	87.1 percentage of participants
Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye IOP Target ≤16 mm Hg	71.2 percentage of participants	87.1 percentage of participants
Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye IOP Target ≤15 mm Hg	64.4 percentage of participants	83.9 percentage of participants
Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye IOP Target ≤14 mm Hg	59.3 percentage of participants	80.6 percentage of participants
Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye IOP Target ≤13 mm Hg	47.5 percentage of participants	71.0 percentage of participants
Percentage of Participants Achieving Specific IOP Targets at Month 12 in Medication-free Eye IOP Target ≤12 mm Hg	37.3 percentage of participants	58.1 percentage of participants

SECONDARY outcome

Timeframe: Month 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall number analyzed are the number of participants with data available for analyses.

IOP is a measurement of the fluid pressure inside the eye. Specific percentage IOP lower targets included ≥25%, ≥30%, ≥35%, ≥40% ≥45%, and ≥50% IOP reduction. Medication-free eye at Month 12 was defined as no IOP-lowering medication was used to the study eye at Month 12.

Outcome measures

Measure	XEN-45 Gel Stent n=59 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=31 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes ≥25% IOP Reduction	67.8 percentage of participants	77.4 percentage of participants
Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes ≥30% IOP Reduction	57.6 percentage of participants	77.4 percentage of participants
Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes ≥35% IOP Reduction	50.8 percentage of participants	77.4 percentage of participants
Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes ≥40% IOP Reduction	44.1 percentage of participants	67.7 percentage of participants
Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes ≥45% IOP Reduction	30.5 percentage of participants	58.1 percentage of participants
Percentage of Participants Achieving Specific Percentage IOP Lower Targets From Baseline at Month 12 With Medication-free Eyes ≥50% IOP Reduction	27.1 percentage of participants	58.1 percentage of participants

SECONDARY outcome

Timeframe: Month 12

Population: Safety Population included all enrolled participants that have undergone study glaucoma surgery.

Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice.

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Use	98.9 percentage of participants	97.7 percentage of participants

SECONDARY outcome

Timeframe: Month 12

Population: Safety Population included all enrolled participants that have undergone study glaucoma surgery.

Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The time of administration was classified into two categories as: Before Procedure and After Procedure.

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Based on Time of Administration Before Procedure	37.9 percentage of participants	56.8 percentage of participants
Percentage of Participants With Intraoperative Adjunctive Antifibrotic Therapy Based on Time of Administration After Procedure	61.1 percentage of participants	40.9 percentage of participants

SECONDARY outcome

Timeframe: Month 12

Population: Safety Population included all enrolled participants that have undergone study glaucoma surgery.

Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The mode of administration was classified into two categories as: Injection and Other. Other includes all other modes of administration apart from injection.

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Participants With Different Modes of Administration of Intraoperative Adjunctive Antifibrotic Therapy Injection	98.9 percentage of participants	84.1 percentage of participants
Percentage of Participants With Different Modes of Administration of Intraoperative Adjunctive Antifibrotic Therapy Other	0 percentage of participants	13.6 percentage of participants

SECONDARY outcome

Timeframe: Month 12

Population: Safety Population included all enrolled participants that have undergone study glaucoma surgery.

Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The volume of administration measured in milliliters (mL) was classified into three categories as: 0.1, 0.2, and Other. Other includes all other volumes apart from 0.1 and 0.2.

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Participants With Different Volumes of Intraoperative Adjunctive Antifibrotic Therapy Other	1.1 percentage of participants	2.3 percentage of participants
Percentage of Participants With Different Volumes of Intraoperative Adjunctive Antifibrotic Therapy 0.1	50.5 percentage of participants	34.1 percentage of participants
Percentage of Participants With Different Volumes of Intraoperative Adjunctive Antifibrotic Therapy 0.2	47.4 percentage of participants	56.8 percentage of participants

SECONDARY outcome

Timeframe: Month 12

Population: Safety Population included all enrolled participants that have undergone study glaucoma surgery.

Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The concentration of administration measured in milligram per milliliter (mg/mL) was classified into three categories as: 0.2, 0.4, and Other. Other includes all other concentrations apart from 0.2 and 0.4.

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Participants With Different Concentrations for Intraoperative Adjunctive Antifibrotic Therapy 0.2	34.7 percentage of participants	36.4 percentage of participants
Percentage of Participants With Different Concentrations for Intraoperative Adjunctive Antifibrotic Therapy 0.4	64.2 percentage of participants	56.8 percentage of participants
Percentage of Participants With Different Concentrations for Intraoperative Adjunctive Antifibrotic Therapy Other	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Month 12

Population: Safety Population included all enrolled participants that have undergone study glaucoma surgery.

Antifibrotic use included MMC which was standardized for both groups and administered according to physician training and practice. The absolute dose of administration measured in microgram per milliliter (µg/mL) was classified into two categories as: 40, and Other. Other includes all other concentrations apart from 40.

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Participants With Different Absolute Dose for Intraoperative Adjunctive Antifibrotic Therapy 40	97.9 percentage of participants	93.2 percentage of participants
Percentage of Participants With Different Absolute Dose for Intraoperative Adjunctive Antifibrotic Therapy Other	1.1 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Day 1, Weeks 1 and 2, and Months 1, 3, 6, 9, and 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Number analyzed is the number of participants with data available for analysis at the given timepoint.

BCVA was performed using a Snellen eye chart with glasses, and the BCVA data collected in the visual acuity electronic case report form (eCRF) page was analyzed. The number of lines read correctly was assessed as the line change from baseline at each follow-up evaluation and were log transformed. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower and negative logMAR value indicating better visual acuity.

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses Change From Baseline at Day 1	-1.4 Log10 (Lines) Standard Error 0.20	-2.5 Log10 (Lines) Standard Error 0.29
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses Change From Baseline at Week 1	-1.2 Log10 (Lines) Standard Error 0.20	-2.4 Log10 (Lines) Standard Error 0.29
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses Change From Baseline at Week 2	-1.1 Log10 (Lines) Standard Error 0.20	-1.6 Log10 (Lines) Standard Error 0.29
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses Change From Baseline at Month 1	-0.6 Log10 (Lines) Standard Error 0.20	-1.1 Log10 (Lines) Standard Error 0.30
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses Change From Baseline at Month 3	-0.4 Log10 (Lines) Standard Error 0.20	-0.5 Log10 (Lines) Standard Error 0.30
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses Change From Baseline at Month 6	-0.4 Log10 (Lines) Standard Error 0.21	-0.4 Log10 (Lines) Standard Error 0.30
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses Change From Baseline at Month 9	-0.4 Log10 (Lines) Standard Error 0.21	-1.0 Log10 (Lines) Standard Error 0.30
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) With Current Glasses Change From Baseline at Month 12	-0.1 Log10 (Lines) Standard Error 0.21	-0.8 Log10 (Lines) Standard Error 0.31

SECONDARY outcome

Timeframe: Baseline (Preoperative) and postoperative Months 1, 3, 6, and 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Number analyzed is the number of participants with data available for analysis at the given timepoint.

Manifest Refraction - Mean Visual Acuity was performed using a Snellen eye chart with glasses. The line change from baseline at each follow-up evaluation in logarithm of the minimum angle of resolution (logMAR) was calculated. A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with a lower logMAR value indicating better visual acuity.

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen Eye Chart in LogMAR Scale Change From Baseline at Month 1	0.05 logMAR Standard Error 0.015	0.10 logMAR Standard Error 0.022
Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen Eye Chart in LogMAR Scale Change From Baseline at Month 3	0.04 logMAR Standard Error 0.016	0.05 logMAR Standard Error 0.022
Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen Eye Chart in LogMAR Scale Change From Baseline at Month 6	0.04 logMAR Standard Error 0.016	0.04 logMAR Standard Error 0.022
Mean Change From Baseline in Manifest Refraction - Mean Visual Acuity Using Snellen Eye Chart in LogMAR Scale Change From Baseline at Month 12	0.01 logMAR Standard Error 0.016	0.07 logMAR Standard Error 0.022

SECONDARY outcome

Timeframe: Month 12

Population: No data is reported due to inaccuracy of the results (autorefractor reading errors).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Preoperative) and Month 12

Population: No data is reported due to inaccuracy of the results (autorefractor reading errors).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Preoperative), Week 1, and Months 1 and 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall Number of Participants Analyzed is the number of participants with data available for analyses at Baseline. Number Analyzed is the number of participants with data available for analyses at Baseline and the given timepoint.

Outcome measures

Measure	XEN-45 Gel Stent n=23 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=12 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Mean Change From Baseline in Surgically Induced Astigmatism - Topography at Selected Sites Change From Baseline at Week 1	0.057 diopters Standard Error 0.1861	0.619 diopters Standard Error 0.2639
Mean Change From Baseline in Surgically Induced Astigmatism - Topography at Selected Sites Change From Baseline at Month 1	0.187 diopters Standard Error 0.1931	0.326 diopters Standard Error 0.2741
Mean Change From Baseline in Surgically Induced Astigmatism - Topography at Selected Sites Change From Baseline at Month 12	0.106 diopters Standard Error 0.1976	0.558 diopters Standard Error 0.2860

SECONDARY outcome

Timeframe: Baseline, Day 1 and Week 2

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall Number of Participants Analyzed is the number of participants with data available for analyses at Baseline. Number Analyzed is the number of participants with data available for analyses at Baseline and the given timepoint.

Outcome measures

Measure	XEN-45 Gel Stent n=21 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=10 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Mean Change From Baseline in Optical Biometry - Anterior Chamber Depth Change from Baseline at Day 1	-0.183 millimeter Standard Error 0.1295	-0.182 millimeter Standard Error 0.1553
Mean Change From Baseline in Optical Biometry - Anterior Chamber Depth Change from Baseline at Week 2	-0.206 millimeter Standard Error 0.1195	-0.427 millimeter Standard Error 0.1732

SECONDARY outcome

Timeframe: Baseline, Day 1 and Week 2

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall Number of Participants Analyzed is the number of participants with data available for analyses at Baseline. Number Analyzed is the number of participants with data available for analyses at Baseline and the given timepoint.

The keratometric values for keratometry (K) measured in 2 meridians (i.e., flat keratometry [K1] and steep keratometry [K2]) along with Delta (D) were determined.

Outcome measures

Measure	XEN-45 Gel Stent n=21 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=12 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D K1, Change from Baseline at Week 2	0.156 diopter Standard Error 0.1973	-0.105 diopter Standard Error 0.2618
Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D K1, Change from Baseline at Day 1	-0.103 diopter Standard Error 0.2195	-0.446 diopter Standard Error 0.2512
Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D K2, Change from Baseline at Day 1	0.373 diopter Standard Error 0.2947	0.783 diopter Standard Error 0.3342
Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D K2, Change from Baseline at Week 2	0.152 diopter Standard Error 0.2626	0.640 diopter Standard Error 0.3499
Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D Delta D, Change from Baseline at Day 1	0.514 diopter Standard Error 0.2967	1.279 diopter Standard Error 0.3372
Mean Change in From Baseline Optical Biometry - Keratometry (K)1, K2, Delta D Delta D, Change from Baseline at Week 2	0.087 diopter Standard Error 0.2636	0.664 diopter Standard Error 0.3527

SECONDARY outcome

Timeframe: Up to Month 12

Population: No tabular data was collected. Photographs were taken at select sites to be used for publication purposes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to Month 12

Population: No tabular data was collected. Photographs were taken at select sites to be used for publication purposes.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Month 12

Population: Safety Population included all enrolled participants that have undergone study glaucoma surgery.

Clinical hypotony was defined as vision reduction (2 lines or more) related to macular changes consistent with hypotony maculopathy (macular folds), optic disc edema, and/or serous choroidal detachments because of low IOP.

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Participants With Clinical Hypotony	23.2 percentage of participants	50.0 percentage of participants

SECONDARY outcome

Timeframe: Up to Month 12

Population: Safety Population included all enrolled participants/eyes that have undergone study glaucoma surgery.

Eyes with IOP 6 mm Hg or less at any time point and relevant clinical assessment (vision reduction [2 lines or more] related to macular changes consistent with hypotony maculopathy [macular folds], optic disc edema, anterior chamber status, and/or serous choroidal detachments because of low IOP) of these eyes at those time points were assessed. Only data from study eyes are included. The worse eye was selected as the study eye if both eyes met the inclusion criteria. The worse eye was defined using the visual field MD at Baseline, with the worse eye having the most negative MD. In cases where the MD was the same in both eyes to two decimal places, the worse eye was defined as the eye with the higher IOP.

Outcome measures

Measure	XEN-45 Gel Stent n=95 eyes Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 eyes Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Eyes With IOP 6 mm Hg or Less at Any Time Point and Relevant Clinical Assessment	13.7 percentage of eyes	29.5 percentage of eyes

SECONDARY outcome

Timeframe: Median follow-up of 366.0 days

Population: Safety Population included all enrolled participants that have undergone study glaucoma surgery.

An adverse event(AE)is any untoward medical occurrence in a clinical investigation participant administered drug; it does not necessarily have to have a causal relationship with the treatment. Intraoperative AESIs included- Detached Descemet's membrane,iris damage,lens contact,vitreous bulge or loss,anterior chamber bleeding,retrobulbar hemorrhage,conjunctival perforation,conjunctival or scleral flap tearing,shallow anterior chamber with peripheral iridocorneal touch,flat anterior chamber with iridocorneal touch extending to the pupil,device malfunction identified prior to implantation,and choroidal hemorrhage of effusion. Only categories with at least one participant with event in the study eye are reported. The worse eye was selected as the study eye if both eyes met inclusion criteria. The worse eye was defined using visual field MD at Baseline, with the worse eye having the most negative MD. If MD was same in both eyes to two decimal places, the worse eye=eye with higher IOP.

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Participants With Specific Intraoperative Adverse Events of Special Interest (AESIs) Anterior Chamber Bleeding	1.1 percentage of participants	4.5 percentage of participants
Percentage of Participants With Specific Intraoperative Adverse Events of Special Interest (AESIs) Other	1.1 percentage of participants	2.3 percentage of participants
Percentage of Participants With Specific Intraoperative Adverse Events of Special Interest (AESIs) Conjunctival Buttonhole	0.0 percentage of participants	2.3 percentage of participants
Percentage of Participants With Specific Intraoperative Adverse Events of Special Interest (AESIs) Iris Damage	0.0 percentage of participants	2.3 percentage of participants

SECONDARY outcome

Timeframe: Median follow-up of 366.0 days

Population: Safety Population included all enrolled participants that have undergone study glaucoma surgery.

AE=any untoward medical occurrence in a clinical investigation participant administered drug;it does not necessarily have to have a causal relationship with the treatment. TEAE is an AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug. Postoperative AEs included but were not limited to: angle recession, anterior chamber changes, BCVA loss,bleb leak, blebitis, cataract, choroidal effusion, chronic pain, corneal edema, cyclodialysis, Dellen, device malfunction, endophthalmitis, fixed dilated pupil, hyphema, hypotony, implant issues, increase in corneal thickness/IOP, explant, iridodialysis, iritis, loss of eye, etc.Worse eye=eye if both eyes met inclusion criteria. Worse eye was defined using visual field MD at Baseline, with worse eye having the most negative MD. In cases where MD was the same in both eyes to two decimal places, worse eye was defined as eye with higher IOP.

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Participants With Postoperative Treatment-Emergent Adverse Events of Special Interest (AESIs)	66.3 percentage of participants	86.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to Month 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery.

The categories = Worsening (<-2), No Change (≥-2 and ≥2), Improving (>2) and Missing were used for determining BCVA worst line change from Baseline. Only categories with at least one participant with event are reported.

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Participants With BCVA Worst Line Change From Baseline Across Follow-Up Worsening	36.84 percentage of participants	56.82 percentage of participants
Percentage of Participants With BCVA Worst Line Change From Baseline Across Follow-Up No Change	63.16 percentage of participants	40.91 percentage of participants
Percentage of Participants With BCVA Worst Line Change From Baseline Across Follow-Up Missing	0.0 percentage of participants	2.27 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Preoperative) and Month 12

Population: Safety Population included all enrolled participants that have undergone study glaucoma surgery. Overall number analyzed are the number of participants with data available for analyses.

Pachymetry was measured as average central corneal thickness (microns/micrometer) change from Baseline.

Outcome measures

Measure	XEN-45 Gel Stent n=64 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=30 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Pachymetry Based on Change From Baseline In Average Central Corneal Thickness	-2.0 micrometer (µm) Standard Deviation 21.41	6.4 micrometer (µm) Standard Deviation 12.44

SECONDARY outcome

Timeframe: Baseline and Month 12

Population: Safety Population included all enrolled participants that have undergone study glaucoma surgery. Overall number analyzed are the number of participants with data available for analyses.

All visual field examination data were collected and reported as mean deviation by Humphrey machine.

Outcome measures

Measure	XEN-45 Gel Stent n=68 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=34 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Change From Baseline in Visual Field Examinations Analyzed by Machine Type	-0.051 decibel (dB) Standard Deviation 4.5578	-0.356 decibel (dB) Standard Deviation 3.0171

SECONDARY outcome

Timeframe: Median follow-up of 366.0 days

Population: Safety Population included all enrolled participants that have undergone study glaucoma surgery.

AE=any untoward medical occurrence in a clinical investigation participant administered drug; it does not necessarily have to have a causal relationship with the treatment. An SAE was defined as any untoward medical occurrence that: 1) results in death, 2) is life-threatening, 3) requires inpatient hospitalization or prolongation of existing hospitalization, 4) results in persistent or significant disability/incapacity, 5) leads to a congenital anomaly/birth defect in the offspring of the participant or 6) is a medically important event that satisfies any of the following: a) May require intervention to prevent items 1 through 5 above. b) May expose the participant to danger, even though the event is not immediately life threatening or fatal or does not result in hospitalization. ADEs and SADEs are AEs and SAEs that are caused by the device

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Percentage of Participants With at Least One Adverse Event (AE), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs) and Serious ADEs (SADEs) TEAEs	74.7 percentage of participants	93.2 percentage of participants
Percentage of Participants With at Least One Adverse Event (AE), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs) and Serious ADEs (SADEs) TESAEs	9.5 percentage of participants	4.5 percentage of participants
Percentage of Participants With at Least One Adverse Event (AE), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs) and Serious ADEs (SADEs) TEADEs	0.0 percentage of participants	0.0 percentage of participants
Percentage of Participants With at Least One Adverse Event (AE), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs) and Serious ADEs (SADEs) TESADEs	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Preoperative) to Month 6

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall number analyzed are the number of participants with data available for analyses.

The SHPC-18 is an 18-item questionnaire that asks participants being treated for glaucoma questions about eye symptoms or problems they may experience. There are two domains: Local Eye Symptoms (7 items) subscale score 0 to 700 divided by 7 and Visual Function Problem (11 items) subscale score 0 to 1100 divided by 11. The scores of each subscale ranges from from 0 (not at all) to 100 (a lot); higher scores indicate more bother. A frequency score was calculated by summing the individual response scores of each item, and ranges from 0 to 7 for Local Eye Symptom and from 0 to 11 for Visual Function. A total bothersome score for the SHPC-18 is calculated by summing all 18 items scores, resulting in a range from 0 to 1800, then dividing the sum by 18, to create a total bothersome score ranging from 0 (not at all) to 100 (a lot); higher scores indicate more bother. A negative change from Baseline for all scales and subscales indicates improvement.

Outcome measures

Measure	XEN-45 Gel Stent n=44 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=26 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Patient-reported Outcomes (PRO): Change From Baseline in Symptom and Health Problem Checklist (SHPC-18) Scores Local Eye Symptoms Score	-3.328 score on a scale Standard Error 2.5560	-0.297 score on a scale Standard Error 3.4928
Patient-reported Outcomes (PRO): Change From Baseline in Symptom and Health Problem Checklist (SHPC-18) Scores Vision Function Problem Score	-3.064 score on a scale Standard Error 2.6759	7.443 score on a scale Standard Error 3.6965
Patient-reported Outcomes (PRO): Change From Baseline in Symptom and Health Problem Checklist (SHPC-18) Scores Total Bothersome Score	-3.160 score on a scale Standard Error 2.3564	4.368 score on a scale Standard Error 3.2737
Patient-reported Outcomes (PRO): Change From Baseline in Symptom and Health Problem Checklist (SHPC-18) Scores Local Eye Symptoms Frequency Score	-0.6 score on a scale Standard Error 0.25	-0.1 score on a scale Standard Error 0.34
Patient-reported Outcomes (PRO): Change From Baseline in Symptom and Health Problem Checklist (SHPC-18) Scores Vision Function Problem Frequency Score	-0.7 score on a scale Standard Error 0.37	1.0 score on a scale Standard Error 0.51

SECONDARY outcome

Timeframe: Month 3

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery.

Participants answered the question, "Since your glaucoma surgery, would you consider that you have resumed your usual activities and daily routine?" using the following categories: Not at all, Somewhat, Moderately so, Mostly, Completely.

Outcome measures

Measure	XEN-45 Gel Stent n=95 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine Completely	41.1 percentage of participants	31.8 percentage of participants
PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine Not at all	1.1 percentage of participants	2.3 percentage of participants
PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine Somewhat	4.2 percentage of participants	9.1 percentage of participants
PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine Moderately so	4.2 percentage of participants	4.5 percentage of participants
PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine Mostly	6.3 percentage of participants	20.5 percentage of participants
PRO: Percentage of Participants With Post-Surgical Resumption of Activities and Daily Routine Missing	43.2 percentage of participants	31.8 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Preoperative) and Month 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall Number of Participants Analyzed is the number of participants with data available for analysis at the given timepoint.

WPAI-General Health (GH) is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to general health. It yields 5 sub-scores: hours actually worked, work time missed due to health impairment while working, impairment while working due to health, overall work impairment due to health, activity impairment due to health. These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. A negative change from Baseline indicates improvement.

Outcome measures

Measure	XEN-45 Gel Stent n=5 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=7 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
PRO: Percent Change From Baseline in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment Due to Health	-0.994 percent change Standard Error 12.4333	7.309 percent change Standard Error 10.3287

SECONDARY outcome

Timeframe: Baseline (Preoperative) and Month 12

Population: ITT Population included all enrolled eyes/participants that were randomized to and received study glaucoma surgery (XEN-45 or trabeculectomy). Analyses were based on the randomized surgery. Overall Number of Participants Analyzed is the number of participants with data available for analysis at the given timepoint.

WPAI-General Health (GH) is 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to general health. It yields 5 sub-scores: hours actually worked, work time missed due to health impairment while working, impairment while working due to health, overall work impairment due to health, activity impairment due to health. These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. A negative change from Baseline indicates improvement.

Outcome measures

Measure	XEN-45 Gel Stent n=30 Participants Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=19 Participants Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
PRO: Percent Change From Baseline in WPAI: Percent Activity Impairment Due to Health	-3.1 percent change Standard Error 5.18	10.8 percent change Standard Error 6.53

Adverse Events

XEN-45 Gel Stent

Serious events: 9 serious events

Other events: 59 other events

Deaths: 3 deaths

Trabeculectomy

Serious events: 2 serious events

Other events: 38 other events

Deaths: 1 deaths

Serious adverse events

Measure	XEN-45 Gel Stent n=95 participants at risk Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 participants at risk Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Cardiac disorders CARDIAC ARREST	1.1% 1/95 • Number of events 1 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.	0.00% 0/44 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.
Eye disorders VISUAL ACUITY REDUCED	1.1% 1/95 • Number of events 1 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.	0.00% 0/44 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.
Infections and infestations CORONA VIRUS INFECTION	2.1% 2/95 • Number of events 2 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.	0.00% 0/44 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.
Infections and infestations ENDOPHTHALMITIS	1.1% 1/95 • Number of events 1 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.	0.00% 0/44 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.
Infections and infestations PERIORBITAL CELLULITIS	1.1% 1/95 • Number of events 1 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.	0.00% 0/44 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.
Infections and infestations PNEUMONIA	1.1% 1/95 • Number of events 1 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.	0.00% 0/44 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.
Infections and infestations SEPSIS	1.1% 1/95 • Number of events 1 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.	0.00% 0/44 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.
Injury, poisoning and procedural complications FALL	0.00% 0/95 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.	2.3% 1/44 • Number of events 1 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.
Investigations INTRAOCULAR PRESSURE INCREASED	1.1% 1/95 • Number of events 1 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.	0.00% 0/44 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.
Nervous system disorders PARKINSON'S DISEASE	1.1% 1/95 • Number of events 1 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.	0.00% 0/44 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.
Product Issues DEVICE EXTRUSION	1.1% 1/95 • Number of events 1 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.	0.00% 0/44 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY DISTRESS SYNDROME	0.00% 0/95 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.	2.3% 1/44 • Number of events 1 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.

Other adverse events

Measure	XEN-45 Gel Stent n=95 participants at risk Participants underwent at least one preoperative visit and had XEN-45 gel stent implantation on Day 0 (The day of surgery).	Trabeculectomy n=44 participants at risk Participants underwent at least one preoperative visit and had trabeculectomy as per standard of care in each investigative center on Day 0 (The day of surgery).
Eye disorders CHOROIDAL EFFUSION	2.1% 2/95 • Number of events 2 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.	9.1% 4/44 • Number of events 5 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.
Eye disorders DRY EYE	3.2% 3/95 • Number of events 3 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.	6.8% 3/44 • Number of events 3 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.
Eye disorders GLAUCOMA	0.00% 0/95 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.	6.8% 3/44 • Number of events 3 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.
Eye disorders HYPOTONY OF EYE	23.2% 22/95 • Number of events 24 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.	50.0% 22/44 • Number of events 32 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.
Eye disorders PUNCTATE KERATITIS	2.1% 2/95 • Number of events 2 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.	6.8% 3/44 • Number of events 3 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.
Eye disorders VISUAL ACUITY REDUCED	37.9% 36/95 • Number of events 59 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.	54.5% 24/44 • Number of events 39 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.
Injury, poisoning and procedural complications CONJUNCTIVAL FILTERING BLEB LEAK	0.00% 0/95 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.	15.9% 7/44 • Number of events 9 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.
Injury, poisoning and procedural complications HYPHAEMA	6.3% 6/95 • Number of events 6 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.	6.8% 3/44 • Number of events 3 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.
Investigations INTRAOCULAR PRESSURE INCREASED	20.0% 19/95 • Number of events 23 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.	11.4% 5/44 • Number of events 6 • Median follow-up of 366.0 days All-Cause Mortality: Enrolled Population included all participants with study eyes for which participants had signed the informed consent form (ICF). SAEs and Other AEs: Safety Population included all enrolled participants with study eyes that have undergone study glaucoma surgery.

Additional Information

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