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.

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.

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.

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.

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.

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.

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.

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.

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.

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. Specific IOP targets included following IOP values (in mm Hg): ≤18, ≤17, ≤16, ≤15, ≤14, ≤13, ≤12 mm Hg.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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 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.

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.

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

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.

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.

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.

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.

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.

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

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.

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.

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.

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

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

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.

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.

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.

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

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

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.

Safety Population included all enrolled participants 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.

Safety Population included all enrolled participants/eyes 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.

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.

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

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.

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

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.

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.

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

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

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.

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.

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.

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.

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.

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.

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.