XEN-45 Gel Stent Versus Trabeculectomy in Glaucoma: Gold-Standard Pathway Study (GPS)

This is a multi-center, randomized, parallel group, prospective, open-label clinical trial to
evaluate the ability of XEN to reduce IOP and reduce the amount of topical IOP-lowering
medications in subjects poorly controlled on topical therapy. Patients will be randomized
2:1, resulting in approximately 190 eyes being implanted with XEN and approximately 95 eyes
will be receiving trabeculectomy. Subjects will be screened for enrollment and eligible
candidates will be approached to ascertain interest in study participation. Study duration
will be approximately 12 months.

Inclusion Criteria:

- Open-angle glaucoma where the Intraocular pressure (IOP) is not controlled when using
topical IOP-lowering glaucoma medication

- Best-corrected baseline Snellen visual acuity of 20/80 or better

- Visual field mean deviation no worse than -15.0 dB

- Medicated IOP ≥18 mmHg and ≤44 mmHg

- Subjects not anticipated to require any ocular surgery (e.g., cataract surgery) in
either eye up to 12 months from the time of inclusion

- Area of healthy, free, and mobile conjunctiva in the target area (superior bulbar
conjunctiva)

- Trabecular meshwork must be visible (with Shaffer angle grade ≥2 in the target
quadrant)

- Failed ab-interno canal or suprachoroidal MIGS procedures (such as i-Stent, CyPass,
GATT, ABiC, Kahook dual blade goniotomy, etc.) are allowed.

Exclusion Criteria:

- Subject has active neovascular, uveitic or angle recession glaucoma or any glaucoma
associated with vascular disorders

- Subject has had prior ab externo incisional glaucoma surgery (such as trabeculectomy,
viscocanalostomy, canaloplasty, tube shunts of any type, collagen implants, etc.),
conjunctival filtering surgery, transscleral cycloablative procedures (such as
cyclophotocoagulation, micro pulse cyclophotocoagulation, cryotherapy, UC3, etc.) or
prior major conjunctival surgery (i.e., scleral buckle)

-. Clinically significant inflammation or infection within 30 days before the
preoperative visit (e.g., blepharitis, conjunctivitis, severe ocular surface disease,
keratitis, uveitis, herpes simplex infection)

- Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival
pathologies (e.g., pterygium) in the target area

- History of corneal surgery, corneal opacities, or corneal disease

- Central corneal thickness ≤490μm or ≥620μm

- Vitreous present in the anterior chamber

- Aphakic

- Subject has had prior intraocular surgery in either eye within ≤3 months before the
preoperative visit (including phacoemulsification)

- History of complicated cataract surgery (e.g. with visual impairment, e.g. vitreous
loss, ACIOL, perhaps sutured IOL or scleral fixated IOL, prior CME, etc.)

- Presence of intraocular silicone oil

- Active diabetic retinopathy, proliferative retinopathy, choroidal neovascularization,
branch retinal vein occlusion, central retinal vein occlusion, geographic atrophy, or
other ophthalmic disease or disorder that could confound study results or impaired
episcleral venous drainage (e.g., Sturge-Weber or nanophthalmos, Axenfeld-Reiger, ICE,
etc.

- Known or suspected allergy or sensitivity to drugs required for the protocol
(including anesthesia), or any of the device components (e.g., bovine or porcine
products, or glutaraldehyde)

- Pregnant or nursing women and those planning a pregnancy during the study period.

- Participation in another drug or device clinical trial concluding within 30 days
before the preoperative visit