Myra Vision announced the first patient enrollment and treatment with its Calibreye Glaucoma Therapy (TGT) Surgical System in the Shifamed portfolio company’s investigational device exemption (IDE)-cleared clinical study.
How exciting! But first—a refresh on this technology.
The Calibreye Titratable Glaucoma TGT Surgical System is the medical device company’s proprietary, novel technology designed for treatment in—you guessed it—glaucoma patients.
- Specifically: This is a next-generation aqueous shunt drainage device with a low-profile design and material properties that help to conform to the shape of the eye.
Its purpose: To give ophthalmologists more aqueous outflow control, enabling them to attain optimal intraocular pressure (IOP) control and resulting in a more personalized therapy (with minimal complications) for patients.
And how exactly does this work?
See below for a visual of the implantation process, in which the Calibreye allows for slit lamp-based outflow adjustments to accommodate patients’ changing needs.
As for its titratable outflow: Check out our rundown on the system’s three distinct outflow channels and their capabilities.
Now to the IDE trial.
Dubbed ADAPT, the FDA gave the all-clear for this prospective, multicenter, non-randomized, open-label trial in August 2025.
Based on what the company has shared thus far, we know:
- The intent: To evaluate the Calibreye System’s safety and effectiveness in optimizing IOP reduction among patients undergoing glaucoma surgery.
- The patients: Up to 70 refractory glaucoma patients
- The outcome measure: A 12-month primary effectiveness endpoint
Any details to share on the first patient treatment?
Yes! As Myra Vision reported, this initial patient case was conducted by David Godfrey, MD, a glaucoma specialist, at Glaucoma Associates of Texas.
Per Dr. Godfrey: “The potentially groundbreaking Calibreye System is the first adjustable glaucoma shunt in the United States, aiming to enable clinician-directed postoperative adjustment to support individualized IOP management.”
- No further details were shared on the patient’s response to the device implant.
This may be premature … but do we know when results could be available?
Great question. In response to Glance's request for information on this, a representative of the company noted that Myra Vision "may share the data about a year after the last patient enrolled is treated."
However: The rep added that the company does not yet have visibility into when patient enrollment will complete.
- "As the study progresses, we can provide a more definitive timeline," they said.
Got it. Any prior clinical data on the device's performance?
That we do have. Myra Vision actually initiated a first-in-human (FIH) trial on the Calibreye System in September 2023.
Fast forward to March 2025: The company shared positive initial outcomes from the study during last year’s American Glaucoma Society (AGS) meeting.
- See here for details on the international trial’s setup and open-angle glaucoma (OAG) participants.
… and those initial outcomes?
Among the reported 3 month findings: 100% of Calibreye System devices were implanted successfully as well as:
- 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
- No patients requiring bleb needling procedures