Oticara has reported that its Phase II trial of a steroid cream optimised for nasal mucosa showed durable symptom improvement.
The cream is intended for individuals experiencing persistent chronic rhinosinusitis symptoms following endoscopic sinus surgery.
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Oticara presented the data regarding post-surgical treatment for chronic rhinosinusitis at the American Academy of Otolaryngology – Head and Neck Surgery Foundation 2025 Annual Meeting & OTO EXPO in Indianapolis, Indiana, US.
The open-label, multicentre Phase II trial involved 24 participants and assessed a single-dose, in-office application of the cream, which was provided in pre-filled syringes.
This treatment aims to ensure precise and targeted delivery, administered under an ear, nose and throat (ENT) specialist’s endoscopic guidance.
The study met its co-primary goals, demonstrating improvements in the Sino-Nasal Outcome Test (SNOT-22) and 4 Cardinal Symptom Score (4CSS).
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By GlobalDataSenior author and presenter of the study Anders Cervin said: “In this Phase II trial, the treatment clearly delivered durable improvements for patients who remained symptomatic after surgery.
“These results suggest that Oticara’s treatment could integrate seamlessly into ENT practice, while offering meaningful relief to a population with few remaining options.”
The 4CSS showed a mean reduction of 3.82 points at week three, representing a 32.6% improvement from baseline. Over half of the patients (58.3%) met responder criteria.
The SNOT-22 exceeded the minimum clinically important difference at weeks three, six and nine.
Patient-reported outcomes showed that 91.7% of participants reported improvement on the Patient Global Impression of Severity.
Physician-assessed outcomes demonstrated improvements in the nasal polyp burden and Modified Lund-Kennedy Score.
The treatment was well tolerated, with no severe, serious or fatal adverse events and no clinically significant changes observed in intraocular pressure or serum cortisol levels.
