Ondine reports 40% reduction in surgical-site infections in phase 3 trial
pharmafile | September 9, 2026 | News story | |Â Â Ondine Biomedical, nasal photodisinfection technology, phase 3 trial, surgical-site infectionsÂ
Ondine Biomedical has reported a 40% relative reduction in 30-day surgical-site infections (SSIs) in a 5,188-patient phase 3 trial of its nasal photodisinfection technology.
The LANTERN trial, conducted across 18 hospitals in the US and Canada, evaluated Ondine’s nasal photodisinfection alongside standard care against standard care alone for the prevention of SSIs. The result met the study’s pre-specified Bayesian criterion for treatment benefit.
The company said the treatment’s safety profile was consistent with more than a decade of previous clinical experience, with no treatment-related serious safety concerns identified in the preliminary review. More detailed efficacy, safety and subgroup analyses are still being completed.
SSIs can lead to prolonged hospital stays, readmissions and additional healthcare costs, while prevention is becoming increasingly important as antimicrobial resistance limits the effectiveness of antibiotic-based approaches.
Ondine’s technology, marketed as Steriwave outside the US, uses a photosensitising agent activated by red light to produce a rapid antimicrobial effect. Applied to the nose before surgery, it is intended to eliminate potentially pathogenic microorganisms that can act as a reservoir for infection. The company says its non-antibiotic, multi-pathway mechanism has a low potential for driving microbial resistance.
The company now plans to seek a pre-New Drug Application meeting with the US Food and Drug Administration (FDA) to discuss the detailed LANTERN results and its planned regulatory submissions. The results will also be submitted for presentation at a scientific meeting and publication in peer-reviewed journals.
Carolyn Cross, CEO of Ondine Biomedical, said the results represented an important milestone in the company’s development programme and highlighted the potential importance of rapid, broad-spectrum, non-antibiotic approaches to infection prevention.
Ondine’s nasal photodisinfection technology is authorised for nasal decolonisation in Canada, the UK and certain other markets, but is not currently approved or commercially available in the US.
Related Content
Genentech shares data from phase 3 trials of Vabysmo for retinal vein occlusion treatment
Genentech has announced positive topline long-term results from its global phase 3 BALATON and COMINO …
CytoDyn’s COVID-19 treatment shows positive results in Phase III trial
Biotechnology company CytoDyn has shown positive results in its Phase III CD12 trial of Vyrologix, …
