US FDA Gives Green Light to Trial of Long Bridge’s Prosthetic Capsular Bag — Illustrations from the Long Bridge Medical website show the LensOne with IOL seated (left) and the procedure to insert and fixate the device (right). The US FDA granted breakthrough device designation to LensOne in December 2023.

Long Bridge Medical announced March 26 that the US FDA had signed off on its investigational device exemption (IDE) submission, allowing the company to proceed with a pivotal trial of LensOne, its prosthetic capsular bag candidate.

Long Bridge, of South San Francisco, California, said LensOne is designed to enable reliable secondary intraocular lens (IOL) fixation in patients with absent or compromised lens capsule support in eyes that are poor candidates for anterior chamber IOLs.

The FDA granted breakthrough device designation to LensOne in December 2023, citing its potential to address an unmet need in patients with no FDA-approved surgical options.

Long Bridge said conditions requiring secondary IOL placement include postsurgical aphakia, trauma, and spontaneous IOL dislocation. Current off-label surgical alternatives—including scleral suture fixation and the Yamane technique—are technically demanding and associated with significant complication rates, Long Bridge said. (In the Yamane technique, the haptics of a three-piece IOL are brought through the sclera and then cauterized for fixation.)

Frank Brodie, MD, co-founder of Long Bridge Medical, said surgeons need a reliable, reproducible tool to address such complex cases.

LensOne, intended to re-create the structure and function of the native capsular bag, is suspended in the eye by three fixation arms which are anchored transsclerally and subconjunctivally. Its internal cavity is designed to securely hold and center the IOL. The implantation technique is designed to integrate with established lens exchange workflows and instrumentation, Long Bridge said.

Data from a first-in-human trial of 15 patients demonstrated favorable safety and performance, Long Bridge said. The first patient was implanted in Australia in May 2023.

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