Ondine Biomedical (AIM:OBI) has reported that just 0.31% of patients in its Phase 3 LANTERN trial experienced a treatment-related adverse event, with all eight cases described as mild.
The AIM-listed medical device company, which develops light-activated antimicrobial therapies to prevent hospital-acquired infections, presented the safety and tolerability results alongside research partner HCA Healthcare Research Institute at IDWeek 2026 in Washington, D.C.
The safety analysis covered 2,543 participants who received Ondine's Steriwave nasal photodisinfection between 27 December 2024 and 27 April, out of the trial's full 5,188-patient population across 18 hospitals in the US and Canada.
Among those treated, eight experienced a treatment-related adverse event, including temporary nasal soreness, mild burning or transient bleeding, and none were serious.
Patient acceptance was high: 2,249 of 2,310 respondents rated the treatment "very bearable" or "bearable", while 2,203 of 2,309 said they were "very likely" or "likely" to accept it again if prescribed.
"These safety results from the LANTERN trial demonstrate that preoperative nasal photodisinfection was exceptionally well tolerated by patients in a real-world clinical setting", said Dr Ken Sands, chief epidemiologist of HCA Healthcare.
Chief executive Carolyn Cross said the low rate and mild nature of adverse events, together with high patient acceptance, "reinforce the practical suitability of nasal photodisinfection for preoperative use."
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The tolerability data follow the September announcement that LANTERN met its prespecified Bayesian primary efficacy endpoint, showing a 40.5% lower risk of 30-day surgical site infection when nasal photodisinfection was added to standard care.
Ondine is now funding commercial expansion and production and quality system work as it prepares a US regulatory submission, having targeted a pre-NDA meeting with the FDA in the first quarter of 2027.