Myra Vision Inc., a Shifamed portfolio company, has launched its first-in-human (FIH) trial of its Calibreye System, designed to optimize intraocular pressure (IOP) reduction in moderate to severe glaucoma patients.
Remind me about Myra Vision.
But first, here’s a refresh on Shifamed, a medical tech innovation hub. Myra Vision is focused on developing its novel technology to enable safe outflow control for maximum reduction of IOP while simultaneously reducing complexity and complication rates.
To note, back in June 2023, the company secured $25M in financing to support this FIH clinical trial.
Now the Calibreye System.
As a first-of-its-kind titratable glaucoma therapy, the Calibreye System is a next-generation aqueous shunt drainage device with titratable outflow control for achieving optimal IOP reduction.
How does it work?
Its engineering is intended to give glaucoma clinicians outflow control by providing a personalized therapy for glaucoma patients.
Once implanted, the shunt “is designed to allow non-invasive in-office increases or decreases in outflow as a patient’s individual treatment needs change,” according to Myra Vision.
And this study?
The prospective, non-randomized, open-label feasibility study (NCT05885022) is assessing the system’s clinical procedure, safety, and overall performance in treating open-angle glaucoma (OAG).
An estimated 39 patients (ages 18+) are being enrolled, per Clinical Trials.
Patient criteria?
Participants must have an IOP of ≥ 18mmHg and ≤ 45mmHg at the baseline visit and a visual field mean deviation score of -3dB or worse.
See here for the full inclusion and exclusion criteria.
What’s being measured?
Primary outcome measures are listed as the following:
- Percentage change in IOP from baseline to 12-month visit
- Occurrence of adverse events (number and percentage)
The secondary outcome measure is the change in the number of glaucoma medications used compared to baseline.
When can we expect data?
According to Clinical Trials, the study is slated for completion in April 2025. Stay tuned for milestone updates!