Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.

• GORE Glaucoma Drainage Implant (Device): GDI-01

Primary outcomes

• Percent Change in MDIOP [12 Months]: Percent change in MDIOP at the 12-Month Visit compared to the Baseline Visit.
• Proportion of subjects achieving a ≥ 20% reduction in MDIOP [12 Months]: Proportion of subjects achieving a ≥ 20% reduction in mean diurnal IOP (MDIOP) at 12 months while maintaining the same or fewer number of ocular hypotensive medication classes compared to the Baseline Visit

Sex: All, ages: 46 Years to any

Inclusion Criteria:

* Diagnosis of primary open-angle glaucoma (POAG) with IOP uncontrolled by medical therapy and failed surgical treatment
* Medicated IOP of >=20 mmHg
* Shaffer angle grade >= 2 in target quadrant
* Area of free and mobile conjunctiva without extensive scarring or fibrosis
* At least 46 years old

Exclusion Criteria:

* Closed-angle and secondary glaucomas
* Any pathology or condition (including prior glaucoma filtration or conjunctival surgery) that prevents implantation of the study device in the target quadrant
* Diagnosis of degenerative visual disorders
* History of corneal transplantation, prior corneal surgery, corneal opacities inhibiting visualization, or clinically significant corneal disease pathology
* Non-study eye with BCVA worse than 20/200
* Pregnant or nursing women; or women of childbearing potential not using medically acceptable birth control