OcuMedex — First-in-Human Clinical Trials of the Vizio™ Aqueous Microshunt
OcuMedex, Inc. (Maple Grove, MN, USA) is developing the Vizio™ Aqueous Microshunt, an investigational glaucoma device designed to reduce intraocular pressure (IOP) by draining aqueous humor from the anterior chamber to the eye's surface — rather than inward or into an enclosed space, as with other devices — using a patented design for precise flow control. Vizio™ is currently undergoing human clinical trials. bioaccess® managed the first-in-human clinical work in Latin America. Vizio™ remains investigational; nothing here implies FDA clearance or approval. Last reviewed: July 2026.
Study facts
- Sponsor / company: OcuMedex
- Indication / area: Ophthalmology
- Country: Colombia
- Study type: First-in-Human (FIH)
Key metrics
- Device: Vizio™ Aqueous Microshunt
- Indication: Glaucoma (IOP reduction)
- Status: In human clinical trials
- Company HQ: Maple Grove, MN, USA
The challenge
Glaucoma is a leading cause of irreversible blindness worldwide. OcuMedex needed disciplined first-in-human clinical experience for the Vizio™ Aqueous Microshunt to advance its U.S. regulatory strategy while preserving capital.
bioaccess® solution
bioaccess® partnered with glaucoma surgery centers in Colombia, supporting regulatory and ethics approvals, surgeon training on the implantation technique, patient enrollment, and structured IOP and safety follow-up under ISO 14155-aligned protocols.
Results
- First-in-human implantations of the Vizio™ Aqueous Microshunt supported by bioaccess® in Latin America
- Vizio™ currently undergoing human clinical trials (investigational device)
- Novel drainage mechanism: aqueous humor drained from the anterior chamber to the eye's surface
- Patented design intended to enable precise control of aqueous outflow
- Clinical operations delivered under ISO 14155-aligned protocols
Frequently asked
- What did bioaccess® do for OcuMedex?
- bioaccess® partnered with glaucoma surgery centers in Colombia, supporting regulatory and ethics approvals, surgeon training on the implantation technique, patient enrollment, and structured IOP and safety follow-up under ISO 14155-aligned protocols.
- Where was the OcuMedex First-in-Human (FIH) study run?
- The OcuMedex First-in-Human (FIH) study was executed in Colombia by bioaccess® in the ophthalmology area.
- What was the outcome of the OcuMedex study?
- Reported outcomes for OcuMedex's device: First-in-human implantations of the Vizio™ Aqueous Microshunt supported by bioaccess® in Latin America; Vizio™ currently undergoing human clinical trials (investigational device); Novel drainage mechanism: aqueous humor drained from the anterior chamber to the eye's surface.
Run a similar trial: Clinical trials in Colombia
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