Myra Vision announced today that it received FDA investigational device exemption (IDE) approval for its Calibreye system.
The Shifamed portfolio company can now initiate its ADAPT prospective, non-randomized, open-label trial for Calibreye. It expects to evaluate the titratable glaucoma therapy (TGT) surgical system in up to 70 refractory glaucoma patients. The study has a 12-month primary effectiveness endpoint.
Campbell, California-based Myra Vision designed the Calibreye system to put aqueous outflow control in the hands of ophthalmologists. It enables the delivery of personalized therapy while minimizing complications, according to a news release.
Once implanted, the Calibreye aqueous shunt enables slit lamp-based outflow adjustments as individual patient needs change. Myra Vision aims for the system to become the first aqueous shunt to provide adjustable and reversible outflow control. It hopes to offer an alternative to traditional glaucoma surgery, which includes trabeculectomy and tube shunt implants, as well as more recently developed less invasive surgical devices. The company says these options still fail to offer adjustability that meets individual clinical needs.
“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 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.”
