Myra Vision Receives FDA Conditional Approval to Begin IDE Study in Glaucoma

Myra Vision has announced that the US Food and Drug Administration (FDA) has issued a conditional approval letter for its Investigational Device Exemption (IDE) application, enabling the company to launch the ADAPT study in the United States.

About the ADAPT Study

The ADAPT trial is a prospective, nonrandomized, open-label study that will assess the safety and effectiveness of the Calibreye Titratable Glaucoma Therapy (TGT) Surgical System in up to 70 patients with refractory glaucoma. The study’s primary effectiveness endpoint will be measured at 12 months.

“Lowering IOP is the only known treatment to prevent optic nerve damage and preserve vision for glaucoma patients. Current therapies are not always successful at lowering IOP, and safer approaches are needed,” said David S. Friedman, MD, PhD, MPH, Director of the Glaucoma Service at Mass Eye and Ear at Mass General Brigham in Boston and medical monitor for the trial. “I look forward to kicking off this important study to see if the successful early clinical experience with the Calibreye System is demonstrated in a larger clinical trial. For lowering eye pressure, the Calibreye technology offers a potentially safer solution for patients.”

Calibreye TGT Surgical System Overview and Features

The Calibreye System is designed to put aqueous outflow control directly in the hands of ophthalmologists, enabling a personalized therapy approach while aiming to reduce complications.

Once implanted, the system’s aqueous shunt allows for slit lamp–based adjustments to outflow over time, adapting to each patient’s changing needs. If approved, the Calibreye System would become the first aqueous shunt offering both adjustable and reversible outflow control.