Myra Vision Secures FDA Approval to Initiate US IDE Study in Glaucoma

The ADAPT study will evaluate the safety and effectiveness of the company's Calibreye™ Titratable Glaucoma Therapy™ (TGT) Surgical System

CAMPBELL, Calif., Aug. 12, 2025 /PRNewswire/ -- Myra Vision, a Shifamed portfolio company, announced today that the U.S. Food and Drug Administration (FDA) has issued a conditional approval letter for its Investigational Device Exemption (IDE) application to initiate the ADAPT study. The prospective, nonrandomized, open-label trial will evaluate the safety and effectiveness of Myra's Calibreye™ Titratable Glaucoma Therapy™ (TGT) Surgical System in up to 70 refractory glaucoma patients with 12-month primary effectiveness endpoint.

"Lowering IOP is the only known treatment to prevent optic nerve damage and preserve vision for glaucoma patients. Current therapies are not always successful at lowering IOP, and safer approaches are needed," stated David S Friedman, MD, PhD, 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. For lowering eye pressure, the Calibreye technology offers a potentially safer solution for patients."

The Calibreye System is engineered to put aqueous outflow control in the hands of ophthalmologists and give them the opportunity to provide personalized therapy while minimizing complications. Once implanted, the Calibreye aqueous shunt is designed to enable slit lamp-based outflow adjustments as individual patient needs change. The Calibreye System aims to be the first aqueous shunt to provide adjustable and reversible outflow control.

"This FDA approval to initiate our ADAPT study marks a significant milestone for our company as we advance our mission to deliver innovation to glaucoma care," stated Robert Chang, President and Chief Executive Officer of Myra Vision. "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."

The leading cause of irreversible blindness, glaucoma affects an estimated 80M people worldwide.¹ There is no cure for glaucoma, so patients and their caregivers seek to reduce or eliminate disease progression through intraocular pressure (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.

The Calibreye System is for investigational use only and is not for sale in the U.S. or outside the U.S.

About Myra Vision, Inc.

Myra Vision, a privately held portfolio company of Shifamed LLC, is developing a new aqueous shunt that is designed to allow safe personalized IOP control, based on the specific needs of the patient, while also reducing complexity and complication rates. To learn more about Myra Vision, please visit www.myravision.com.

About Shifamed, LLC.

Founded by serial entrepreneur Amr Salahieh, Shifamed LLC is a highly specialized medical innovation hub focused on developing solutions that accelerate time to market, reduce risk, increase impact, and forge a path toward a world where patients are able to lead longer, healthier lives. To learn more about Shifamed, please visit www.shifamed.com.

Media Contact:
Charlene Herndon
SPRIG Consulting
[email protected] 

¹ 2024 Market Scope Glaucoma Surgical Device

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SOURCE Myra Vision, Inc.