Intranasal Steroid Cream Post-Surgery Improves CRS Symptoms in Phase 2 Trial

Oticara’s intranasal steroid cream significantly improved symptoms of hard-to-treat post-surgical chronic rhinosinusitis (CRS), meeting the primary endpoint in the phase 2 trial with gains in the 4 Cardinal Symptom Score (4CSS) and the Sino-Nasal Outcome Test (SNOT-22) at week 3.1

This successful phase 2 data, announced by the company on October 13, 2025, was also 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. The presentation was called “In-office, intra-sinus application of 0.0644% betamethasone dipropionate nasal cream (nasal-BMDP): Phase 2 OT-007b trial results.”2

“For ENTs, it is rare to see a therapy that can be delivered in-office in just minutes and still achieve such strong outcomes,” senior author and presenter Anders Cervin, MD, PhD, FRACS, honorary professor of otolaryngology at the University of Queensland in Sweden, said in a statement. “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.”

OT-007B, a phase 2, multicenter, open-label study, evaluated a single-dose, in-office application of the intranasal betamethasone dipropionate cream supplied in pre-filled syringes. An Ear, Nose, and Throat (ENT) physician delivered this treatment to 23 participants aged 30 – 77 years (39.1% male; 54.5% eosinophilic).3 Participants were included in the study if they had ENT-confirmed chronic rhinosinusitis, underwent functional endoscopic sinus surgery ≥ 6 months before enrollment, had an endoscopic bilateral nasal polyp score of ≤5, a disease severity visual analog scale of > 2, and a bodyweight of ≥ 40 kg at baseline.

The trial met its co-primary endpoints, with the intranasal steroid cream bringing significant improvements in 4CSS and SNOT-22.1 At week 3, patients showed a 3.82-point reduction in 4CSS (32.6% from baseline; P < .0001), with 58.3% meeting the responder criteria.

Participants achieved improvements in SNOT-22 that surpassed the minimum clinically important difference (MCID) at weeks 3, 6, and 9. SNOT-22 scores reduced by -17.15 (P <.0001) at week 3, -10.70 (P =.0019) at week 6, and -10.49 (P =.0025) at week 9. Additionally, all SNOT-22 subdomains significantly improved at week 3 (P ≤.001) and met their respective MCIDs.1

The study also demonstrated significant gains in several secondary endpoints, including patient-reported improvements in sense of smell. In total, 91.7% of patients reported improvements on the Patient Global Impression of Severity scale.1

Additionally, investigators observed improvements in the Modified Lund-Kennedy Score and nasal polyp burden. Participants experienced sustained symptom relief throughout the 9-week study.1

The intranasal steroid cream was well-tolerated, with no severe adverse events. Most events were mild (73.9%). The cream also did not lead to clinically significant changes in intraocular pressure or serum cortisol levels.1

Oticara enhances steroid delivery in CRS, allowing the medication to remain in place for days. Pharmacokinetic analysis shows that a single intra-sinus application results in systemic steroid exposure roughly equivalent to a 10 mg oral prednisone dose, over 90% lower than a standard 5-day oral course, yet still provides robust local therapeutic benefit.1

“CRS patients who remain symptomatic after surgery represent one of the hardest-to-treat groups for ENTs,” said Oticara Chief Executive Officer Chris Marich, MBA, in a statement.1 “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.”

References

1. Oticara Announces Positive Phase 2 Results Demonstrating Durable Symptom Improvement with Novel Steroid Nasal Cream for Hard-to-Treat Post-Surgical Chronic Rhinosinusitis. Oticara. October 13, 2025.

2. Oticara to Present Late-Breaking Phase 2 Data on Novel Steroid Nasal Cream for Hard-to-Treat Post-surgical Chronic Rhinosinusitis Patients at AAO-HNSF 2025 Annual Meeting. Business Wire. October 2, 2025. https://www.businesswire.com/news/home/20251002628236/en/Oticara-to-Present-Late-Breaking-Phase-2-Data-on-Novel-Steroid-Nasal-Cream-for-Hard-to-Treat-Post-surgical-Chronic-Rhinosinusitis-Patients-at-AAO-HNSF-2025-Annual-Meeting. Accessed October 13, 2025.

3. Cervin A, Ooi E, Walker A, et al. In-office, intra-sinus application of 0.0644% betamethasone dipropionate nasal cream (nasal-BMDP): Phase 2 OT-007b trial results. Late-breaker presented at the American Academy of Otolaryngology – Head and Neck Surgery Foundation (AAO-HNSF) 2025 Annual Meeting & OTO EXPO on October 13, 2025.