Evaluate the Safety and Efficacy of the Vizio Aqueous Microshunt for the Treatment of Refractory Glaucoma

Glaucoma is a leading cause of irreversible blindness in the world and remains a largely unmet clinical need, especially for trial participants with refractory glaucoma. Available aqueous drainage devices may reduce IOP, but often require continued use of medications. Ocumedex is testing the Vizio Aqueous Microshunt (VAM), a promising medical device engineered to safely and consistently lower IOP to a threshold (approximately 12 mmHg) that may halt further damage to the optic nerve without the use of supplemental medication. The Vizio Aqueous Microshunt is a next generation device initially developed by MicroOptx, Inc. In early 2023, Innomedex, LLC acquired the assets of MicroOptx and formed the company, Ocumedex Inc. Ocumedex is now sponsoring the Vizio Clinical Study based on the product development that was conducted by MicroOptx under an ISO13485 compliant quality system inclusive of all development testing that is required prior to human use.

MicroOptx, developed a first-generation device which was named the Beacon Aqueous Microshunt. The Beacon device had undergone early clinical trials in the United States, Canada and Germany in which 55 trial participants were implanted and clinically followed. The results of this clinical work clearly demonstrated the efficacy endpoint of significantly reducing intraocular pressure and alleviating the need for medications. The safety endpoint of the Beacon device had an adverse event rate that was higher than expected and hence further product development was initiated. The elevated adverse event rate was attributed to healing response of the first-generation material, implantation technique andtrial participant selection. Based on this information, the next generation device, Vizio, was developed with a new implant material which has demonstrated significantly improved healing in GLP animal studies.

Additionally, physician training and proctoring has been refined to ensure proper device implantation as well as refined inclusion/exclusion criteria to ensure proper trial participant selection.

Ocumedex is committed to developing technology that is safe and efficacious for the treatment of trial participants suffering from the devasting disease of glaucoma. With product improvements validated by bench and animal testing in addition to clinical trial rigor implemented, the Vizio product is set to initiate human implants and have a meaningful impact for trial participants.

Additionally, unlike other surgical options available, the Vizio device shunts aqueous humor from the anterior chamber to the surface of the eye. This distinction is important: 1) Vizio drains aqueous humor into an open space with a known pressure (atmospheric), which may improve predictability and consistency of IOP control (vs. draining into a closed space, such as bleb or episcleral venous pressure); and 2) Shunting aqueous humor to the tear film, providing lubrication to the eye and improving ocular surface symptoms which are common in trial participants with glaucoma.

Inclusion Criteria:

1. Age 22-85 years

2. Refractory glaucoma describes eyes diagnosed with glaucoma specific to one of the following:

   • uncontrolled by maximally tolerated medical therapy
   • failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery or tube shunt)
   • failed one or more cilioablative procedures (e.g., cryotherapy, cyclodiode therapy)
   • or have any other condition (e.g., conjunctival scarring, uveitis) in which conventional incisional glaucoma surgery like trabeculectomy would be more likely to fail than for an eye with uncomplicated primary open angle glaucoma.

3. Primary open-angle or traumatic glaucoma.

4. Medicated DIOP ≥25 mmHg and ≤45 mmHg on maximum-tolerated medical therapy that is stable for at least 30 days.

5. Best-corrected baseline visual acuity of light perception or better in study eye.

6. Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:

   • Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage;
   • Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles; or
   • Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue

7. Visual field mean deviation (MD) by Humphrey Visual Field:

Visual field defects consistent with glaucomatous optic nerve damage and mean deviation worse than -3 dB in the study eye; and at least one of the following two findings:

• A cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level on the pattern deviation (PD) plot;

• Glaucoma hemi-field test "outside normal limits". 8. At least two contiguous clock hours of intact conjunctiva near the limbus between clock hours of 10:00 and 02:00 in the study eye. 9. Adequate space in the anterior chamber by Spaeth Grade C, D or E for iris insertion (with indentation). 10. Participant has the understanding, ability, and willingness to fully comply with study procedures and postoperative care instructions. 11. Participant understands, is capable and competent to sign the informed consent. Exclusion Criteria

  1. Active neovascular conditions such as active iris or corneal neovascularization, or active proliferative retinopathy in study eye.

  2. Pigmentary glaucoma in study eye.

  3. Angle-closure glaucoma in study eye.

  4. Pseudoexfoliation syndrome in study eye

  5. Iridocorneal endothelial syndrome in study eye.

  6. Uveitic glaucoma in the study eye.

  7. Epithelial or fibrous downgrowth in the study eye.

  8. Corneal conditions in study eye inhibiting normal incisional healing (e.g. Fuch's dystrophy) or impair visualization of implant inside the anterior chamber.

  9. Prior intraocular surgery in study eye within ≤6 months before the preoperative visit (including phacoemulsification).

  10. Central corneal endothelial cell count of less than 1600 cells/mm2 in study eye.

  11. Anticipated need for ocular surgery or retinal laser procedure in the study eye within the 12-month follow-up period.

  12. Need for glaucoma surgery combined with other ocular procedures in study eye at implant (e.g. cataract surgery, penetrating keratoplasty, or retinal surgery).

  13. Unwilling to discontinue contact lens use in the study eye after surgery.

  14. Central corneal thickness ≤490μm or ≥620μm in the study eye.

  15. Clinically significant inflammation or infection in the study eye within 60 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection) or any systemic infection. For purposes of this study, clinically significant is considered any such condition requiring prescription therapy.

  16. Any condition that prevents the device implantation in the superior region of the study eye.

  17. Vitreous in the study eye anterior chamber for which a vitrectomy is anticipated.

  18. Functionally significant cataract in the study eye.

  19. Other clinical conditions:

      1. Poorly controlled diabetes (Type I or Type II) as determined by HbA1c >8 within 3 months of implant.
      2. Cancer requiring treatment during the duration of the study.
      3. Any drugs (e.g.: immunosuppressive drugs) or co-morbidity that might inhibit wound healing.

  20. Participation in any other clinical study during participation in this study.

  21. Engage in activities that involve submerging their head under water, such as diving or swimming.

  22. Women who are (i) pregnant, (ii) nursing, (iii) planning a pregnancy and (iv) of childbearing potential not using a reliable method of contraception.

  23. Life expectancy <1 year. Note: If both eyes are eligible, the eye with the worse BCVA should be selected