Myra Vision Initiates First-in-US Trial of Adjustable Glaucoma Shunt System

Myra Vision (搜索)搜索该词条, a Shifamed (搜索)搜索该词条 portfolio company, has treated the first patient in its ADAPT clinical study evaluating the Calibreye Titratable Glaucoma (搜索)搜索该疾病 Therapy (TGT) Surgical System. The initial case was conducted by Dr. David Godfrey at Glaucoma Associates of Texas (搜索)搜索该词条, representing a significant milestone in the company's U.S. regulatory pathway following FDA approval of its Investigational Device Exemption (IDE) application in August 2025.

First Adjustable Glaucoma Shunt in the United States

"We are thrilled to participate in the ADAPT trial and to have treated our first patient with the Calibreye System," said Dr. Godfrey. "The potentially groundbreaking Calibreye System is the first adjustable glaucoma (搜索)搜索该疾病 shunt in the United States, aiming to enable clinician-directed postoperative adjustment to support individualized intraocular pressure (搜索)搜索该靶点 (IOP) management."

The Calibreye system is designed to provide ophthalmologists with adjustable control over aqueous outflow, allowing for personalized therapy and the ability to modify treatment as patient needs evolve. Once implanted, the aqueous shunt enables slit lamp-based outflow adjustments as individual patient requirements change over time.

ADAPT Trial Design and Objectives

The ADAPT trial is a prospective, multicenter, nonrandomized open-label study that will enroll up to 70 refractory glaucoma (搜索)搜索该疾病 patients with a 12-month primary effectiveness endpoint. The clinical investigation will evaluate the safety and effectiveness of the titratable glaucoma therapy system, designed to optimize IOP reduction in patients undergoing glaucoma surgery.

"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," stated Dr. Ike Ahmed, Director of the Alan S. Crandall Center for Glaucoma (搜索)搜索该疾病 Innovation at John A. Moran Eye Center, Utah, and a Myra Vision (搜索)搜索该词条 advisor. "Titratable glaucoma therapy has the potential to provide a meaningful solution for the significant number of these patients in need."

Addressing Unmet Medical Need

Glaucoma (搜索)搜索该疾病, the leading cause of irreversible blindness, affects an estimated 80 million people worldwide. There is no cure for glaucoma, so patients and their caregivers seek to reduce disease progression through IOP control. Traditional glaucoma surgery, including trabeculectomy and tube shunt implants, and more recently developed less invasive surgical devices, do not offer adjustability to meet individual clinical needs.

"We are excited to have enrolled the first patient in our ADAPT clinical study. This is a significant accomplishment for our organization, and an important step towards delivering the Calibreye System to physicians and patients," commented Robert Chang, President and Chief Executive Officer of Myra Vision (搜索)搜索该词条. "Subconjunctival filtration procedures like Calibreye are currently being evaluated in a small percentage of eligible moderate to advanced glaucoma (搜索)搜索该疾病 patients who require significant pressure reduction. The personalized IOP control provided by Calibreye will offer physicians greater confidence to address the needs of these underserved patients."

Regulatory Status

The Calibreye System is for investigational use only and is not for sale in the U.S. or outside the U.S. The company aims to be the first aqueous shunt to provide adjustable and reversible outflow control, with the potential to minimize complications through its personalized approach to glaucoma (搜索)搜索该疾病 management.