#FDA Approval #Myra Vision #Calibreye

Myra Vision's FDA Approval for Glaucoma Study

Myra Vision, a company within the Shifamed portfolio, recently reached a pivotal milestone by receiving conditional approval from the U.S. Food and Drug Administration (FDA) to commence an Investigational Device Exemption (IDE) study. The approved study, named ADAPT, will evaluate the efficacy and safety of Myra's cutting-edge Calibreye™ Titratable Glaucoma Therapy™ (TGT) Surgical System in patients suffering from refractory glaucoma.

The ADAPT study is anticipated to enroll up to 70 participants and aims to assess the system's primary effectiveness over a span of 12 months. According to medical experts, this technology could considerably enhance patients' quality of care by offering a more personalized approach to managing intraocular pressure (IOP), which is crucial for preventing optic nerve damage in glaucoma patients.

Dr. David S. Friedman, a leading ophthalmologist and medical monitor for the study, underscored the significance of this innovation: “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, which highlights the need for safer treatment options.” He expressed optimism about the Calibreye System, noting that it has demonstrated success in early clinical experiences and hopes that these results will be replicated on a larger scale during the ADAPT study.

The Calibreye System has been meticulously designed to empower ophthalmologists with enhanced control over aqueous outflow. This allows for targeted therapy tailored to the individual needs of patients while minimizing the risks associated with complications. Once the shunt is implanted, practitioners can adjust the outflow based on real-time assessments, ensuring an adaptable treatment plan that evolves alongside the patient’s condition.

Robert Chang, President and CEO of Myra Vision, emphasized the importance of this FDA approval in advancing their mission to transform glaucoma care.