NATICK, Mass. — Allurion Technologies has submitted the final module of its Pre-Market Approval (PMA) application to the U.S. Food and Drug Administration for the Allurion Balloon, its non-surgical weight loss device. The submission includes new analyses from the pivotal AUDACITY study that the company says meet both of the trial’s pre-specified co-primary endpoints.
The AUDACITY study evaluated the safety and effectiveness of the Allurion Balloon, a swallowable intragastric balloon, in a randomized, controlled setting involving 550 participants. Subjects were randomized 1:1 to either two cycles of the Allurion Balloon or a control group receiving moderate-intensity lifestyle therapy. The primary endpoints were measured at Week 48, roughly eight weeks after the second balloon naturally passed from the body.
Initial topline results had shown that while the study met its first co-primary endpoint — a responder rate at 48 weeks — the second endpoint fell slightly short. The average weight loss difference between the treatment and control groups at Week 48 was 3.77%, with a 2.69% super-superiority margin, just under the pre-specified 3% margin.
However, new analyses included in the final PMA module used imputation methods to adjust for higher-than-expected weight loss in the control group. With these adjustments, the difference in weight loss between groups increased to 4.34% at 48 weeks, with a super-superiority margin of 3.14% (p = .0142), exceeding the required threshold. At 40 weeks, the adjusted difference grew to 4.90%, with a margin of 3.75% (p = .0006).
“We are thrilled to submit our PMA on schedule with additional analyses that support the effectiveness of the Allurion Balloon,” said Shantanu Gaur, M.D., Founder and CEO of Allurion. “We believe that these analyses are more suitable for the trends observed in both groups in the AUDACITY Study and further strengthen our positive topline data. With the PMA now submitted, we are looking forward to working with the FDA toward an approval.”
The AUDACITY trial is the first FDA pivotal study on an intragastric balloon to report primary outcomes beyond nine months. The Allurion Balloon is designed to pass naturally from the body and does not require endoscopy or anesthesia for placement or removal.
If approved, the Allurion Balloon could offer a new, less invasive treatment option for patients seeking medically managed weight loss.
