Myra Vision Secures FDA Approval to Initiate US-Based IDE Study in Glaucoma

Myra Vision announced today that the FDA has issued a conditional approval letter for its investigational device exemption (IDE) application, allowing the company to initiate the ADAPT study.

The prospective, nonrandomized, open-label trial will evaluate the safety and effectiveness of the Calibreye Titratable Glaucoma Therapy (TGT) Surgical System in up to 70 refractory glaucoma patients, with a 12-month primary effectiveness endpoint.

“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.”

The Calibreye System is designed to put aqueous outflow control in the hands of ophthalmologists, enabling personalized therapy while aiming to minimize complications. Once implanted, the device’s aqueous shunt allows for slit lamp-based outflow adjustments over time as individual patient needs change. The Calibreye System, if approved, would be the first aqueous shunt with adjustable and reversible outflow control.