Myra Vision, a Shifamed portfolio company, has earned U.S. Food and Drug Administration (FDA) approval for its Investigational Device Exemption (IDE) application to begin its ADAPT study.

The trial will assess the company’s Calibreye titratable glaucoma therapy (TGT) surgical system in up to 70 refractory glaucoma patients with a 12-month primary effectiveness endpoint. The Calibreye aqueous shunt was designed to give ophthalmologists control over aqueous outflow, providing the opportunity for personalized therapy and minimal complications.

Once the shunt is implanted, it enables slit lamp-based outflow adjustments as patient needs change. Myra Vision hopes Calibreye will be the first aqueous shunt with adjustable and reversible outflow control.

Tradition glaucoma procedures like trabulectomy and tube shunt implants—even minimally invasive glaucoma surgery (MIGS) devices—aren’t adjustable to meet clinical needs. Current therapies are not always successful at lowering IOP, and safer approaches are needed, said David S. Friedman, MD, Ph.D., 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,” Dr. Friedman told the press. “For lowering eye pressure, the Calibreye technology offers a potentially safer solution for patients.”

Myra Vision president and CEO Robert Chang said the FDA approval to initiate the company’s ADAPT study marks a significant milestone for our company as its advance the mission to deliver innovation to glaucoma care.

“We look forward to initiating our clinical program in the United States and evaluating our technology’s potential to address a critical unmet need for these underserved patients,” said Chang.