LensOne™ Presents Novel Solution to Unmet Ophthalmic Need
WASHINGTON, D.C. – December 18, 2023 – The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation to the LensOne™ Prosthetic Capsule, an innovative device designed to enable stable intraocular lens (IOL) fixation in patients without adequate capsular support.
The Breakthrough Devices Program is intended to expedite the development and review of medical technologies that have the potential to provide more effective treatment for life-altering conditions. Through this designation, Long Bridge Medical will receive prioritized interaction with the FDA, including more frequent communications and the opportunity for streamlined clinical and regulatory pathways.
LensOne™ is designed to recreate the physiologic structure of the native capsular bag, providing a stable, centered, and planar platform for IOL implantation using familiar surgical techniques. By restoring a more natural anatomic environment, the device aims to address longstanding challenges associated with IOL fixation in the absence of capsular support.
The company plans to continue clinical development of LensOne™ as it advances toward regulatory approval.