Industry

FDA Clears Long Bridge Medical to Initiate US Pivotal Clinical Study for LensOne Prosthetic Capsular Bag

Eyewire+6d ago2 min read

The US FDA has cleared initiation of Long Bridge Medical’s Investigational Device Exemption (IDE) study for LensOne, the company's prosthetic capsular bag, which is designed to enable reliable secondary IOL fixation in patients with absent or compromised lens capsule support in eyes that are poor candidates for anterior chamber IOLs (ACIOL). The approval of the IDE application enables initiation of the Golden Gate pivotal trial, a prospective, multicenter study evaluating the safety and effectiveness of LensOne in patients with IOL dislocation who are poor candidates for ACIOL. The clearance builds on Long Bridge Medical’s previously granted FDA Breakthrough Device Designation, which recognized the device's potential to address an unmet need in a patient population with no FDA-approved surgical options. A significant number of patients in the United States have conditions that require secondary IOL placement, including post-surgical aphakia, trauma, and spontaneous IOL dislocation. Current surgical alternatives, including scleral suture fixation and the Yamane technique, may be technically demanding and associated with significant complication rates and may 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," said Frank Brodie, MD, Cofounder of Long Bridge Medical. "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, which demonstrated a favorable safety and performance profile, justifying further evaluation in a US-based pivotal study. Results from that study were featured in a presentation by J Michael Jumper, MD, President of the American Society of Retina Specialists at the 2025 annual meeting.

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AI Summary

Quick Take

The FDA has cleared Long Bridge Medical to begin the Golden Gate pivotal trial for LensOne, a prosthetic capsular bag designed for secondary IOL fixation. This device targets patients with compromised capsule support who cannot receive anterior chamber IOLs, aiming to provide a standardized, reproducible alternative to technically demanding off-label techniques.

Why It Matters

Managing aphakia or dislocated IOLs in the absence of capsular support remains one of the most challenging scenarios in anterior segment surgery. Currently, surgeons often rely on complex off-label maneuvers—such as scleral suture fixation or the Yamane intrascleral haptic fixation—which are technically demanding and prone to complications. LensOne represents a potential shift toward a dedicated, FDA-approved surgical solution that could simplify these complex cases and improve long-term stability and visual outcomes for patients with trauma or spontaneous IOL dislocation.

Key Details

The LensOne device previously received FDA Breakthrough Device Designation for addressing an unmet need in patients with no FDA-approved surgical options.
The Golden Gate trial follows successful 12-month first-in-human data from a 15-patient cohort which demonstrated a favorable safety and performance profile.
The prosthetic bag is designed to enable reliable secondary IOL fixation in eyes with absent or compromised lens capsule support.
Target conditions for the device include post-surgical aphakia, ocular trauma, and spontaneous IOL dislocation.
Results from the initial first-in-human study were presented by the President of the American Society of Retina Specialists at the 2025 annual meeting.

Study Snapshot

Design

Prospective, multicenter pivotal trial (Golden Gate trial)

Population

Patients with IOL dislocation who are poor candidates for anterior chamber IOLs (ACIOL)

Practice Implications

Surgeons should monitor the progress of the Golden Gate trial as a potential future standard of care for complex secondary IOL placements. If successful, this device could reduce the reliance on technically demanding manual fixation techniques that currently carry risks of haptic erosion, suture degradation, or inconsistent IOL centration.

Who's Affected

Cataract SurgeonsRetina SpecialistsAnterior Segment SurgeonsCornea Specialists

What's Next

Long Bridge Medical will now initiate the multicenter Golden Gate trial to gather the clinical evidence required to support a new standard of care and eventual commercialization in the United States.

Evidence StrengthPreliminary

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