Oticara's novel intranasal steroid cream has demonstrated significant efficacy in treating post-surgical chronic rhinosinusitis (CRS) patients, meeting both co-primary endpoints in a phase 2 clinical trial announced on October 13, 2025. The single-dose, physician-administered treatment achieved substantial symptom improvements that were sustained throughout the nine-week study period.
Trial Design and Patient Population
The OT-007B phase 2, multicenter, open-label study evaluated 23 participants aged 30-77 years (39.1% male; 54.5% eosinophilic) who received a single-dose, in-office application of intranasal betamethasone dipropionate cream. Participants had ENT-confirmed chronic rhinosinusitis and had undergone functional endoscopic sinus surgery at least six months prior to enrollment, with an endoscopic bilateral nasal polyp score of ≤5 and disease severity visual analog scale >2.
Primary Endpoint Results
The trial successfully met its co-primary endpoints with statistically significant improvements in both the 4 Cardinal Symptom Score (4CSS) and Sino-Nasal Outcome Test (SNOT-22). At week 3, patients demonstrated a 3.82-point reduction in 4CSS, representing a 32.6% improvement from baseline (P < .0001), with 58.3% of patients meeting responder criteria.
SNOT-22 scores showed robust improvements that exceeded the minimum clinically important difference (MCID) at multiple timepoints: -17.15 at week 3 (P <.0001), -10.70 at week 6 (P =.0019), and -10.49 at week 9 (P =.0025). All SNOT-22 subdomains significantly improved at week 3 (P ≤.001) and met their respective MCIDs.
Secondary Outcomes and Safety Profile
Secondary endpoints demonstrated broad therapeutic benefits, with 91.7% of patients reporting improvements on the Patient Global Impression of Severity scale. Investigators observed improvements in the Modified Lund-Kennedy Score and nasal polyp burden, while patients experienced enhanced sense of smell.
The treatment exhibited an excellent safety profile with no severe adverse events reported. Most adverse events were mild (73.9%), and the cream did not cause clinically significant changes in intraocular pressure or serum cortisol levels.
Pharmacokinetic Advantages
Pharmacokinetic analysis revealed that systemic steroid exposure from a single intra-sinus application was approximately equivalent to a 10 mg oral prednisone dose—more than 90% lower than a standard five-day oral course—while maintaining robust local therapeutic benefit. This targeted delivery approach allows the medication to remain in place for days.
Clinical Significance
"For ENTs, it is rare to see a therapy that can be delivered in-office in just minutes and still achieve such strong outcomes," said senior author Anders Cervin, MD, PhD, FRACS, honorary professor of otolaryngology at the University of Queensland. "In this Phase 2 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."
Chris Marich, MBA, Chief Executive Officer of Oticara, emphasized the unmet medical need: "CRS patients who remain symptomatic after surgery represent one of the hardest-to-treat groups for ENTs. The Phase 2 results demonstrate that a single application of our nasal-mucosa-optimized steroid cream can provide rapid, durable benefit with an attractive safety profile. We believe this therapy has the potential to transform post-surgical care and address a significant unmet medical need."
The study results were presented as an oral late-breaker at the American Academy of Otolaryngology – Head and Neck Surgery Foundation (AAO-HNSF) 2025 Annual Meeting & OTO EXPO in Indianapolis, and data has been submitted for publication in the organization's peer-reviewed journal. Oticara is advancing preparations for additional clinical trials based on these promising results.
