Myra Vision, a Shifamed portfolio company, has announced it has received conditional FDA approval to initiate its first US Investigational Device Exemption (IDE) trial for the Calibreye™ Titratable Glaucoma Therapy™ (TGT) Surgical System.
The ADAPT study will be a prospective, nonrandomized, open-label trial enrolling up to 70 patients with refractory glaucoma. Its primary endpoint is a 12-month evaluation of safety and effectiveness.
“Lowering IOP is the only known treatment to prevent optic nerve damage and preserve vision for glaucoma patients,” says David S Friedman, Director of the Glaucoma Service at Mass Eye and Ear, Boston. “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 device is designed to provide ophthalmologists with personalized aqueous outflow control, allowing slit lamp–based adjustments as patient needs evolve. Unlike traditional trabeculectomy or fixed tube shunts, Calibreye aims to be the first adjustable and reversible glaucoma shunt, minimizing complications while maintaining flexibility in management.
“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,” says Robert Chang, President and CEO 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."
