Innovative Glaucoma Treatment Begins Clinical Study with Myra Vision's Calibreye System

Myra Vision's Groundbreaking ADAPT Clinical Study for Glaucoma

Myra Vision, a key player in the field of ophthalmic innovation, has made significant strides in glaucoma treatment with the commencement of its ADAPT clinical study. The announcement, made on January 26, 2026, reveals that the first patient has been treated with the company's revolutionary Calibreye™ TGT Surgical System. This milestone is pivotal, representing progress in Myra Vision's regulatory pathway following the FDA's Investigational Device Exemption (IDE) approval received in August 2025.

The ADAPT trial is designed to assess the safety and efficacy of the Calibreye system in patients suffering from refractory glaucoma. With a target enrollment of up to 70 patients, the study will have a primary effectiveness endpoint of 12 months, focusing on optimizing intraocular pressure (IOP) management through personalized treatment plans. The Calibreye system distinguishes itself as the first adjustable glaucoma shunt in the U.S., offering clinicians the unique ability to make postoperative adjustments based on individual patient needs. Dr. David Godfrey, who conducted the first treatment, expressed his enthusiasm, stating, "We are thrilled to participate in the ADAPT trial and to have treated our first patient with the Calibreye System."

The design of this multicenter, nonrandomized open-label study aims to provide a comprehensive understanding of how the Calibreye device, a titratable glaucoma therapy solution, can effectively manage IOP in patients undergoing glaucoma surgery. Once implanted, the Calibreye shunt will facilitate adjustments using a slit lamp, allowing for real-time customization of treatment as patient requirements evolve.

Dr. Ike Ahmed, a prominent figure in glaucoma innovation and advisor to Myra Vision, shared his excitement regarding the trial. He remarked, "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." The potential of titratable therapy to address the significant unmet needs of glaucoma patients is a driving force behind this clinical investigation.

Glaucoma remains the leading cause of irreversible blindness, impacting around 80 million individuals worldwide. While there is presently no cure, effective management of IOP is crucial for slowing the disease's progression and preserving vision. Traditional surgical options, such as trabeculectomy and tube shunt implants, often lack the flexibility to be tailored to individual patient circumstances, creating an urgent need for more adaptive solutions.

President and CEO of Myra Vision, Robert Chang, also commented on the breakthrough, stating, "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." Emphasizing the solution's significance, he noted that traditional subconjunctival filtration procedures are only being considered for a small fraction of glaucoma patients who require significant pressure reductions. The personalized IOP control offered by the Calibreye system represents a crucial advancement that can empower physicians in addressing the needs of these underserved populations.

The Calibreye system, currently designated for investigational use, is not available for sale within or outside the U.S. This innovative technology embodies Myra Vision's commitment to transforming the future of glaucoma care by prioritizing safety and efficacy in personalized patient management. As the clinical study progresses, the impact of the Calibreye system on glaucoma treatment practices will be closely monitored, with hopes for substantial contributions to patient outcomes and quality of life.

For more information about Myra Vision and its innovative solutions, visit Myra Vision's official website.

About Myra Vision, Inc.

Myra Vision is a privately-held company within the Shifamed LLC family, dedicated to creating advanced solutions for glaucoma management that prioritize individualized care.

About Shifamed, LLC

Founded by Amr Salahieh, Shifamed LLC serves as a medical innovation hub that emphasizes accelerating the development of groundbreaking healthcare technologies to enhance patient care and outcomes.