Ondine says nasal photodisinfection cut surgical site infections 40% in Phase 3 study

Ondine Biomedical reported topline Phase 3 results from its LANTERN trial showing a 40% relative reduction in 30-day surgical site infections across 5,188 patients at 18 hospitals in the U.S. and Canada. The company plans to brief the FDA next and pursue U.S. regulatory filing, while the study continues with deeper analyses.

Why it matters: - Surgical site infections can drive longer hospital stays, higher costs and worse outcomes after surgery. - Ondine Biomedical is positioning nasal photodisinfection as a non-antibiotic prevention option at a time when antibiotic resistance remains a concern. - The company also sees a large commercial opportunity in surgical site and ICU infection prevention.

What happened: - Ondine Biomedical reported topline results from the LANTERN Phase 3 pivotal trial. - The study found a 40% relative reduction in 30-day surgical site infections when nasal photodisinfection was added to standard of care. - The trial met its pre-specified primary endpoint. - The study enrolled 5,188 patients across 18 hospitals in the United States and Canada. - Ondine said no treatment-related serious safety concerns were identified in the topline review.

The details: - LANTERN was a multicentre, cluster-randomized, crossover, controlled superiority study. - The trial compared nasal photodisinfection plus standard of care with standard of care alone. - The primary efficacy endpoint measured the relative incidence of surgical site infection within 30 days of surgery. - The preliminary analysis met the trial’s pre-specified Bayesian criterion for treatment benefit. - The U.S. arm included 14 hospitals and recruited most of the patients through HCA Healthcare Research Institute. - The Canadian arm included four tertiary and academic medical centres: Foothills Medical Centre and Rockyview General Hospital in Calgary, University of Alberta Hospital in Edmonton, and Royal Columbian Hospital in New Westminster, British Columbia. - The topline safety profile was consistent with more than a decade of prior clinical experience outside the United States. - More than 250,000 patient treatments have been performed outside the United States in hospitals in Canada, the UK, Mexico, Australia and the EU. - Ondine’s nasal photodisinfection uses a proprietary photosensitising agent activated by red light to create a rapid antimicrobial effect. - Ondine said the approach is designed to have a low potential for microbial resistance because it uses multiple oxidative pathways. - Ondine’s lead product is branded as Steriwave outside the United States. - The product is authorized for nasal decolonisation in Canada, the UK and certain other international markets. - Ondine said the technology is not approved by the FDA and is limited to investigational use only in the United States. - The company also said the total addressable U.S. market for surgical site and ICU infection prevention exceeds $3 billion annually. - The CDC has estimated that an SSI can extend a hospital stay by about 9.7 days and add more than $20,000 in hospitalization costs. - U.S. data have estimated a two- to 11-fold higher risk of death for patients who develop an SSI versus those without an infection. - Public healthcare systems can face longer surgical wait lists because each SSI can displace 2-3 new surgeries.

Between the lines: - The topline data are encouraging, but they are still preliminary and subject to detailed efficacy, safety, subgroup and other analyses. - Ondine is also trying to build a regulatory case for the United States, where the technology still lacks FDA approval. - A positive Phase 3 readout gives the company stronger leverage before a pre-New Drug Application meeting with regulators. - The non-antibiotic angle may matter if hospitals keep looking for infection-prevention tools that do not add to resistance pressure.

What’s next: - Ondine plans to request a pre-New Drug Application meeting with the FDA to review the detailed LANTERN results. - The company expects to discuss future regulatory submissions with the agency. - Ondine will submit the results for presentation at a major scientific meeting. - The company also plans publication in one or more peer-reviewed medical journals. - Further detailed analyses of the primary endpoint and secondary and exploratory endpoints are ongoing.

The bottom line: - Ondine has a potentially important Phase 3 signal for a non-antibiotic surgical infection-prevention tool, but the U.S. path still depends on full data review and FDA engagement.