Rheon Medical announces today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the eyeWatch, the world’s first adjustable glaucoma shunt for the treatment of glaucoma.
Breakthrough Device Designation is granted by the FDA to specific medical devices that have the potential to provide a more effective treatment for life-threatening or irreversibly debilitating diseases. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review while preserving the statutory standards for marketing authorization.
“This marks an important step in our strategy to bring our most innovative glaucoma drainage device to American people suffering from refractory glaucoma”, says Nikos Stergiopulos, CEO and founder of Rheon Medical. “We thank the FDA for the thorough review and the great recognition of the potential of the eyeWatch technology to provide a more effective treatment to such a debilitating disease.”
The eyeWatch has already received the CE-mark in 2019 and is currently marketed in European and Asian markets. Rheon Medical expects to initiate US-based clinical trials evaluating the therapy early 2022.
