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.

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.

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