Ondine Biomedical LANTERN Trial Lowers Infection Risk by 40.5%

Ondine Biomedical Inc. reported that its Phase 3 LANTERN clinical trial met its primary efficacy endpoint, showing a 40.5% lower risk of 30-day surgical site infections compared to standard care. The trial evaluates nasal photodisinfection as a preventative treatment prior to surgical procedures.

Trial Design and Patient Enrollment

The multicenter study enrolled 5,188 patients undergoing various surgical procedures across 18 hospitals located in the United States and Canada, according to an Investing.com report. Clinical evaluations tracked post-operative outcomes over a standard 30-day window following surgery to measure the incidence of surgical site infections.

The Phase 3 LANTERN trial of nasal photodisinfection for preventing surgical site infections met its primary efficacy endpoint, according to company disclosures.

Bayesian Analysis and Efficacy Metrics

Statistical evaluation of the trial relied on a primary Bayesian analysis. The findings demonstrated a 98.2% posterior probability that the nasal photodisinfection treatment successfully reduced the risk of 30-day surgical site infections relative to standard care practices.

The trial yielded an estimated risk ratio of 0.60, translating to the reported 40.5% decrease in relative infection risk. Surgical site infections represent a major challenge in hospital settings, often leading to extended hospital stays, increased treatment costs, and elevated risks of morbidity.

Regulatory Next Steps

Following the completion of the LANTERN trial, Ondine Biomedical plans to request a pre-New Drug Application meeting with the U.S. Food and Drug Administration. The discussions will center on reviewing the Phase 3 clinical data and outlining the pathway for future regulatory submissions.