FDA clears path for US IDE study of Myra Vision’s titratable glaucoma therapy

Myra Vision has secured a conditional approval letter from the FDA for its Investigational Device Exemption (IDE) application to initiate the ADAPT study. The prospective, nonrandomized, open-label trial will assess the safety and effectiveness of the company’s Calibreye titratable glaucoma therapy surgical system in up to 70 patients with refractory glaucoma, with a primary effectiveness endpoint at 12 months.¹

The trial’s goal is to assess both safety and effectiveness of the Calibreye system in a larger patient cohort following encouraging early clinical experience.²

“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,” said 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 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.¹

“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,” said 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 Calibreye system remains investigational and is not available for sale in the US or internationally.

References

1. Myra Vision secures FDA approval to initiate US IDE study in glaucoma. News release. Myra Vision. August 12, 2025. Accessed August 13, 2025. https://www.shifamed.com/press-releases/myra-vision-secures-fda-approval-to-initiate-us-ide-study-in-glaucoma/

2. Myra Vision announces successful first-in-human use of its Calibreye system, a next generation aqueous shunt therapy for patients with moderate to severe glaucoma. News Release. Myra Vision. September 6, 2023. Accessed August 13, 2025. https://www.shifamed.com/press-releases/myra-vision-announces-successful-first-in-human-use-of-its-calibreye-system-a-next-generation-aqueous-shunt-therapy-for-patients-with-moderate-to-severe-glaucoma/