FDA Clears Study for Long Bridge Medical’s Prosthetic Capsular Bag

Long Bridge Medical Inc. has earned U.S. Food and Drug Administration (FDA) clearance to begin its Investigational Device Exemption (IDE) study for LensOne, a prosthetic capsular bag intended to enable reliable secondary intraocular lens (IOL) fixation in patients lacking adequate lens capsule support and for whom anterior chamber intraocular lenses (ACIOL) are not a suitable option.

The IDE approval allows Long Bridge Medical to start its GOLDEN GATE pivotal trial, a prospective, multicenter study evaluating LensOne’s safety and effectiveness in patients with IOL dislocation who are poor ACIOL candidates. The clearance builds on Long Bridge Medical’s previously granted FDA Breakthrough Device Designation, which recognized the device’s potential to address a significant unmet need in a patient population with no FDA-approved surgical options.

Tens of thousands of U.S. patients suffer from conditions requiring secondary IOL placement, including post-surgical aphakia, trauma, and spontaneous IOL dislocation. Current surgical alternatives—including scleral suture fixation and the Yamane technique—are technically demanding, associated with significant complication rates, and lack a standardized, reproducible solution.

“This IDE approval is a pivotal moment for Long Bridge Medical and, more importantly, for the patients who need better options,” Long Bridge Medical Co-Founder Frank Brodie, M.D., said. “We have seen firsthand how challenging these cases are for surgeons and how the off-label options currently used lead to inferior patient outcomes. LensOne was designed to change that—with the potential to give surgeons a reliable, reproducible tool and patients better outcomes in these complex cases. We look forward to evaluating LensOne in the GOLDEN GATE trial and building the clinical evidence needed to support a new standard of care for these patients.”

Long Bridge Medical previously reported 12-month first-in-human data in 15 patients, demonstrating a favorable safety and performance profile justifying further evaluation in a U.S.-based pivotal study. Results from that study were featured in a presentation by J. Michael Jumper, M.D., president of the American Society of Retina Specialists (ASRS) at last year’s annual meeting.

LensOne is an investigational, prosthetic capsular bag designed to restore the anatomic foundation for standard IOL implantation in patients with eyes lacking capsule support who are poor ACIOL candidates. Designed to support various IOL types, LensOne enables surgeons to use familiar techniques in complex cases previously requiring high-risk surgical alternatives. LensOne is limited by U.S. law to investigational use.

Long Bridge Medical is a South San Francisco-based ophthalmic device company developing solutions for complex IOL fixation. The company is backed by ophthalmic surgeons and life science investors committed to advancing vision care.