Myra Vision announced the enrollment of the first patient in its ADAPT clinical study evaluating the Calibreye TGT Surgical System in patients with glaucoma. The milestone follows the FDA approval of Myra Vision’s investigational device exemption (IDE) application in August 2025.

“We are thrilled to participate in the ADAPT trial and to have treated our first patient with the Calibreye System,” said David Godfrey of Glaucoma Associates of Texas, a study investigator. “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 intraocular pressure (IOP) management.”

The ADAPT trial is a prospective, multicenter, nonrandomized, open-label study that will enroll up to 70 patients with refractory glaucoma. The study includes a 12-month primary effectiveness endpoint and is designed to evaluate the safety and effectiveness of Myra Vision’s titratable glaucoma therapy system. The Calibreye System is intended to optimize IOP reduction in patients undergoing glaucoma surgery by allowing postoperative adjustment to meet evolving patient needs.

Once implanted, the Calibreye aqueous shunt is designed to enable slit lamp-based outflow adjustments, offering physicians the ability to personalize therapy over time—an option not available with traditional glaucoma surgical approaches.

“Having been involved in the development of this device for many years, it is incredibly rewarding to see our research come to fruition and now move into the U.S. clinical study,” said Ike Ahmed, MD, Director of the Alan S. Crandall Center for Glaucoma Innovation at the John A. Moran Eye Center in Utah and a Myra Vision advisor. “Titratable glaucoma therapy has the potential to provide a meaningful solution for the significant number of these patients in need.”

“We are excited to have enrolled the first patient in our ADAPT clinical study,” said Robert Chang, President and Chief Executive Officer of Myra Vision, a Shifamed portfolio company. “This is a significant accomplishment for our organization and an important step toward delivering the Calibreye System to physicians and patients. Subconjunctival filtration procedures like Calibreye are currently used in only a small percentage of eligible moderate-to-advanced glaucoma patients who require substantial pressure reduction. The personalized IOP control provided by Calibreye has the potential to give physicians greater confidence in addressing the needs of these underserved patients.”