Ondine Biomedical (AIM:OBI), an AIM-listed developer of light-activated antimicrobial therapies, said its LANTERN Phase 3 pivotal study is approaching its final administrative hurdle, with top-line results now expected within approximately three weeks.
Endpoint adjudication is complete and all queries have been resolved, with site principal investigators currently signing case books, the last required step before database lock.
The company expects that process to conclude within the coming week, after which the locked dataset moves to statistical analysis under a pre-specified Statistical Analysis Plan, with top-line data to follow one to two weeks later.
The LANTERN study, which stands for Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections, is designed to assess whether Ondine's nasal photodisinfection technology, sold outside the US as Steriwave, reduces rates of surgical site infections in patients undergoing surgery.
The trial enrolled 5,188 patients across 14 HCA Healthcare hospitals in the United States and four sites in Canada.
