The FDA has granted Myra Vision, a Shifamed portfolio company, investigational device exemption (IDE) approval to initiate an open-label study on its proprietary Calibreye Titratable Glaucoma Therapy (TGT) Surgical System.
Let’s start with Myra.
The Campbell, California-based medical device company is developing a novel technology that enables safe outflow for maximum intraocular pressure (IOP) reduction—all while reducing complexity and complication rates.
Notably, Myra is a portfolio company of Shifamed, a medical technology innovation hub operating out of Silicon Valley since 2007.
Now, before we get into this novel tech, tell me what IDE means.
An IDE is a regulatory submission to the FDA that allows an investigational device (such as the Calibreye system) to be evaluated for safety and effectiveness in a clinical trial.
Per the federal agency: Such clinical studies are most often conducted to support a premarket approval (PMA) submission of a device for FDA clearance.
- And importantly: All clinical evaluations of investigational devices (unless otherwise exempted) are required to have an approved IDE in place prior to a study’s initiation.
See here for real-world examples of what happens when this protocol isn’t adhered to.
Noted. Next: talk about the Calibreye system.
This is a first-of-its-kind titratable glaucoma therapy designed as a next-generation aqueous shunt drainage device with titratable outflow control for attaining optimal IOP control.
- Take note: Titratable outflow refers to the ability to control and adjust the flow of fluid.
In other words: The device, ideally, gives ophthalmologists more aqueous outflow control and enables a personalized therapy for glaucoma patients—with minimal complications.
Explain how it works.
Once implanted, the device enables slit lamp-based outflow adjustments based on a patient’s changing needs.
More about this titratable outflow: The Calibreye features three distinct outflow channels (standard, medium, and large) with variable capabilities based on four settings:
- Baseline
- Both valves closed; only the standard channel permitting flow
- Greatest outflow resistance and smallest flow area
- Moderate
- Medium channel valve open; standard and medium channels permitting flow
- Moderate outflow resistance / medium flow area
- High
- Large channel valve open; standard and large channels permitting flow
- Low outflow resistance / large flow area
- Maximal
- All valves open; all channels permitting flow
- Least outflow resistance / largest flow area
See here for a visual of each setting.
And how does this system differ from other glaucoma treatments?
As Myra noted, Calibreye offers a unique capability not available with standard glaucoma surgery (minimally-invasive glaucoma surgery [MIGS]) such as trabeculectomy and tube shunt implants—as well as other less-invasive surgical devices.
- That distinction: Adjustability in IOP control to meet patients’ individual clinical needs.
So what do we know about this study?
Dubbed the ADAPT study, it will be designed as a prospective, nonrandomized, open-label trial.
Its purpose: To evaluate the safety and effectiveness of the Calibreye system in up to 70 refractory glaucoma patients.
- Its primary outcome: A 12-month primary effectiveness endpoint
Do we know when it will kick off?
No, a specific timeframe has not yet been established.
Not much to go off of … is there any prior research on the system yet?
There is, actually! Prior and ongoing, really. The company initiated a first-in-human (FIH) trial evaluating the titratable shunt in September 2023.
That study’s purpose: Evaluating the Calibreye’s clinical procedure, safety, and overall performance in treating adult patients diagnosed with open-angle glaucoma (OAG).
- And the data thus far (as of March 2025): Myra released positive 3-month outcomes demonstrating the shunt’s impact in a significant IOP and medication reduction.
Talk numbers.
Take a look at what was presented at the 2025 American Glaucoma Society (AGS) annual meeting, following use of the Calibreye system:
- 44% IOP reduction compared to baseline (average IOP of 12.1 mmHg)
- 88% of patients medication-free, with 100% on less than (or equal to) their baseline medication number
- Over 95% mean medication reduction compared to baseline
See here for more details.
To note: With this study ongoing (expected to conclude in 2028), more data is likely to be released in the near future.
In the meantime, stay tuned for the latest developments—including on the IDE-cleared ADAPT study.