Myra Vision treats first patient in ADAPT trial of Calibreye TGT Surgical System

Myra Vision has treated the first patient in its ADAPT clinical study evaluating the Calibreye TGT Surgical System in patients with glaucoma.

The ADAPT trial is a prospective, multicenter, nonrandomized, open-label study enrolling 70 refractory glaucoma patients with a 12-month primary effectiveness endpoint. The trial will evaluate the safety and effectiveness of the company's titratable glaucoma therapy system, designed to optimize IOP reduction in patients undergoing glaucoma surgery.¹

David Godfrey, MD, Glaucoma Associates of Texas, commented on the trial, saying, "We are thrilled to participate in the ADAPT trial and to have treated our first patient with the Calibreye System. 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 Calibreye system is designed to give ophthalmologists adjustable control over aqueous outflow, allowing personalized therapy and the ability to modify treatment as patient needs evolve. Once implanted, the device enables slit lamp-based adjustments to regulate flow, with the potential to minimize complications. The company notes that its Calibreye system aims to be the first aqueous shunt to provide adjustable and reversible outflow control.²

Ike Ahmed, MD, director of the Alan S. Crandall Center for Glaucoma Innovation, John A. Moran Eye Center, Utah, United States, and a Myra Vision advisor, commented on the trial, saying, "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 clinical study. Titratable glaucoma therapy has the potential to provide a meaningful solution for the significant number of these patients in need."

In August 2025, the US Food and Drug Administration (FDA) approved Belite Bio’s Investigational Device Exemption (IDE) application to initiate the ADAPT trial.²

References:

1. First Patient Treated in Myra Vision's U.S. ADAPT Clinical Study for Glaucoma. Published January 26, 2026. Accessed January 27, 2026. https://www.prnewswire.com/news-releases/first-patient-treated-in-myra-visions-us-adapt-clinical-study-for-glaucoma-302669576.html

2. S Stevenson. FDA clears path for US IDE study of Myra Vision’s titratable glaucoma therapy. Published August 13, 2025. Accessed January 27, 2026. https://www.ophthalmologytimes.com/view/fda-clears-path-for-us-ide-study-of-myra-vision-s-titratable-glaucoma-therapy