A Clinical Trial Comparing the OMNI Surgical System to Standard Medical Treatment in Patients With Primary Open Angle Glaucoma

Inclusion Criteria:

1. Male or female subjects, 45 years or older.

2. History of uncomplicated cataract surgery and posterior chamber intraocular lens (IOL) implantation without compromise to the lens capsule, zonulardehiscence/rupture or vitreous prolapse, 6 months or more prior to Baseline Visit (pseudophakic subjects), OR, phakic and no anticipated need for cataract surgeryover the study duration.

3. Under treatment with a topical prostaglandin F2 analog (e.g. latanoprost,travoprost, bimatoprost, tafluprost) either as monotherapy or in combination withone (1) adjunctive medication for a minimum of 6 weeks prior to the Screening visit.

4. Intraocular pressure (IOP) at the Screening visit of >18 and not exceeding 36 mmHg.

5. Diagnosed with primary open angle glaucoma (POAG).

Exclusion Criteria:

1. Any of the following prior ocular procedures:

• Laser trabeculoplasty ≤180 days prior to baseline

• Durysta ≤12 months prior to baseline unless failure is documented and topicalmedication including a prostaglandin analog is in use as per Inclusioncriterion # 3.

• Implanted with iStent (All types), Cypass, Xen, Express, glaucoma drainingdevice/valve, or Hydrus Device; or

• Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, endoscopiccyclophotocoagulation (ECP), Cyclophotocoagulation or CPC (G probe)

• Retinal laser procedure ≤3 months prior to baseline

2. Concurrent IOP-lowering procedure other than the study procedure (OSS) (e.g. ECP,CPC,etc.)

3. Forms of glaucoma other than POAG including but not limited to: Pigmentary,pseudoexfoliative, acute angle closure, normal tension, pre-perimetric, traumatic,congenital, malignant, uveitic, neovascular or severe glaucoma as documented insubject's medical record.

4. Women of childbearing potential if they are currently pregnant or intend to becomepregnant during the study period; are breast-feeding; or are not in agreement to useadequate birth control methods to prevent pregnancy throughout the study