VividWhite Glaucoma Implant (VW-51) Pivotal Study

Key Inclusion Criteria: Glaucoma in the study eye, meeting the following requirements:

1. Glaucoma is diagnosed by the investigator based upon untreated intraocular pressure,disc appearance and visual field abnormalities, and where the disease type is oneof: Primary open angle glaucoma (POAG); Chronic angle closure glaucoma (CACG) wherethe eye is pseudophakic and a laser iridotomy has previously been performed;Pigmentary open angle glaucoma; Exfoliation open angle glaucoma; Rubeotic glaucomathat is treated and regressed/quiescent; Steroid-induced glaucoma; or Juvenile openangle glaucoma (JOAG).

2. There has been failure of previous treatment for glaucoma (it is 'refractory'),meeting ONE of the following requirements:

i. Failure of medical treatment: inadequate IOP control on maximum tolerated medical therapy.

ii. Failure of previous glaucoma surgery (not more than one operation) with trabeculectomy, Xen/PreserFlo, non-penetrating glaucoma surgery, a previously removed suprachoroidal drainage device, trabecular bypass (using iStents or Hydrus), or cilioablation.

c. The mean diurnal IOP at Screening/Baseline is ≥ 20 mmHg, and ≤ 40 mmHg.

d. The conjunctiva in the target quadrant is healthy, mobile and suitable for glaucoma surgery.

Key Exclusion Criteria: in the study eye:

1. Advanced glaucomatous optic neuropathy that threatens fixation, in the opinion ofthe investigator.

2. The glaucoma type is any of the following: Acute Angle Closure Glaucoma (AACG);Chronic Angle Closure Glaucoma where the eye is phakic; Congenital glaucoma; orSecondary glaucoma of any type not specified in the inclusion criteria, includinginflammatory glaucoma, active neovascular/rubeotic glaucoma, traumatic glaucoma,Iridocorneal Endothelial (ICE) Syndrome, and silicone oil induced glaucoma.

3. Previous glaucoma surgery with: a tube-and-plate glaucoma drainage device (GDD, e.g.Molteno, Baerveldt, Ahmed, Schocket); an in-situ suprachoroidal implant; or multipleprevious operations for glaucoma.

4. Cataract surgery or any other ocular surgery is indicated at the time of studyintervention or is anticipated to be required during the study duration.

5. Central corneal endothelial cell density less than specified age-related thresholdsat screening.

6. Intraocular silicone oil.

7. Significant corneal, retinal, inflammatory or infective ophthalmic pathology (fulldetails specified in the protocol).