Ondine Biomedical Inc. has commenced its Phase 3 clinical trial, named LANTERN, to assess the effectiveness of its non-antibiotic nasal photodisinfection technology in preventing surgical site infections. The first patient was enrolled and treated at Centennial Medical Center in Nashville, Tennessee, marking a significant step in the company's pursuit of FDA approval.
The LANTERN trial is a group-randomized crossover study that will involve approximately 5,000 patients across 14 hospitals. The study, conducted in collaboration with HCA Healthcare, will compare standard infection prevention practices with those including Ondine's Steriwave® nasal photodisinfection technology. Patients undergoing major surgeries, including cardiac, orthopedic, and neurosurgical procedures, will be enrolled.
The core of Ondine's technology is a five-minute, non-invasive nasal decolonization procedure designed to rapidly eliminate infection-causing pathogens without contributing to antimicrobial resistance (AMR). The process involves applying a photosensitive agent to the nostrils, followed by exposure to a specific red light wavelength. This activates the agent, creating an oxidative burst that destroys bacteria, viruses, and fungi in a single treatment.
Carolyn Cross, CEO of Ondine Biomedical, emphasized the importance of the trial in providing healthcare professionals with a tool to combat infection-causing pathogens quickly, without fostering drug resistance or depending on patient compliance, unlike topical antibiotics. "Our US phase 3 trial initiation is an exciting milestone towards making photodisinfection technology available to healthcare professionals who want to rapidly eliminate a broad spectrum of infection-causing pathogens without fuelling drug resistance," said Cross.
The trial is expected to continue enrollment until mid-2025, with preliminary results anticipated in Autumn 2025. Nasal decolonization is a recommended practice in global healthcare guidelines for reducing surgical site infections, as per the 2016 WHO guidelines and the Society for Healthcare Epidemiology of America's 2023 recommendations.
The FDA had previously accepted Ondine's investigational new drug (IND) amendment, with no objections raised during the 30-day statutory review period, paving the way for the trial's commencement.
