Myra Vision announced that the US Food and Drug Administration (FDA) has issued a conditional approval letter for its Investigational Device Exemption (IDE) application to study its Calibreye Titratable Glaucoma Therapy (TGT) Surgical System. The prospective, nonrandomized, open-label ADAPT study will evaluate the system’s safety and effectiveness, and will include up to 70 refractory glaucoma patients with a 12-month primary effectiveness endpoint, according to a company press release.

The Calibreye system is engineered to put aqueous outflow control in the hands of ophthalmologists, enabling them to provide personalized therapy while minimizing complications. Once implanted, the Calibreye aqueous shunt is designed to enable slit lamp-based outflow adjustments as individual patient needs change. Myra Vision states that the Calibreye system aims to be the first aqueous shunt to provide adjustable and reversible outflow control.

“Lowering IOP is the only known treatment to prevent optic nerve damage and preserve vision for glaucoma patients,” 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. “Current therapies are not always successful at lowering IOP, and safer approaches are needed. … the Calibreye technology offers a potentially safer solution for patients,” he said in the press release.