Oticara, a clinical-stage pharmaceutical company focused on developing innovative therapies for chronic rhinosinusitis (CRS), announced encouraging results from its Phase 2 OT-007B clinical trial. The study evaluated Oticara’s proprietary nasal-mucosa-optimized steroid cream in patients suffering from persistent CRS symptoms after endoscopic sinus surgery (ESS). The data were presented as a late-breaking oral podium presentation at the American Academy of Otolaryngology – Head and Neck Surgery Foundation (AAO-HNSF) 2025 Annual Meeting & OTO EXPO℠ in Indianapolis, Indiana.
Durable Symptom Improvement for Hard-to-Treat CRS Patients
“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 Anders Cervin, MD, PhD, FRACS, senior author and presenter of the study. “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.”
Chronic rhinosinusitis, a persistent inflammation of the nasal and sinus mucosa, affects millions worldwide and often continues to cause symptoms even after surgical intervention. Many post-surgical patients have limited treatment options, as oral corticosteroids can cause systemic side effects and topical sprays often fail to reach deeper sinus regions. Oticara’s therapy aims to solve this problem by offering a targeted, long-acting steroid formulation applied directly to the nasal mucosa under endoscopic guidance.
Study Overview and Design
The multicenter, open-label Phase 2 OT-007B study enrolled 24 patients who continued to experience CRS symptoms despite previous endoscopic sinus surgery. Each patient received a single, in-office application of Oticara’s intranasal steroid cream, delivered using a pre-filled syringe for precise, targeted placement. The application was performed by an Ear, Nose, and Throat (ENT) physician under endoscopic visualization, ensuring accurate delivery to inflamed sinus tissue.
The trial’s co-primary endpoints were based on improvements in two established measures of CRS severity — the 4 Cardinal Symptom Score (4CSS) and the Sino-Nasal Outcome Test (SNOT-22). Both endpoints were successfully met, showing statistically significant and clinically meaningful improvements at multiple time points.
Key Efficacy Results
4CSS Results:
Patients demonstrated a mean reduction of -3.82 points (representing a 32.6% improvement from baseline; p<0.0001) at week 3. Notably, 58.3% of patients met responder criteria, highlighting substantial symptom relief in this difficult-to-treat population.
SNOT-22 Results:
Scores decreased significantly across all measured timepoints, surpassing the minimum clinically important difference (MCID):
- Week 3: -17.15 (p<0.0001)
- Week 6: -10.70 (p=0.0019)
- Week 9: -10.49 (p=0.0025)
Furthermore, all SNOT-22 subdomains — including nasal symptoms, sleep, psychological issues, and sense of smell — improved significantly by week 3 (p≤0.001), each meeting or exceeding their respective MCID thresholds.
Patient and Physician-Reported Outcomes
Beyond numerical improvements, patients reported meaningful relief in daily life. 91.7% of participants indicated improvement on the Patient Global Impression of Severity (PGIS) scale, suggesting a high level of satisfaction with symptom reduction. Many also reported restored or improved sense of smell — a key quality-of-life factor often lost in CRS patients.
From a physician’s perspective, investigators observed improvements using the Modified Lund-Kennedy Score (MLKS) and documented reductions in nasal polyp burden. These assessments reinforced the patient-reported outcomes, confirming measurable improvement in mucosal health and sinus patency.
Long-Lasting Benefit and Strong Safety Profile
Perhaps most notably, the single-dose treatment provided durable symptom relief lasting up to nine weeks, the full duration of the study. The extended benefit duration is especially valuable for post-surgical CRS patients who otherwise face recurring inflammation and frequent medication cycles.
The safety profile was excellent. No severe, serious, or fatal adverse events were reported. There were also no clinically significant changes in intraocular pressure (IOP) or serum cortisol levels, indicating minimal systemic steroid exposure.
Mechanism of Action and Pharmacokinetic Insights
Oticara’s proprietary cream is engineered for enhanced mucosal adherence and sustained local steroid delivery. Unlike sprays or irrigations that are quickly cleared from the nasal passages, the cream remains in place for several days, maintaining continuous contact with inflamed tissues.
Pharmacokinetic analyses revealed that systemic steroid exposure after a single intra-sinus application was approximately equivalent to that seen after a 10 mg oral prednisone dose—a more than 90% reduction compared to a typical five-day oral corticosteroid course. Despite this lower systemic exposure, patients achieved strong local therapeutic effects, demonstrating that Oticara’s delivery platform optimizes the balance between efficacy and safety.
Company Perspective and Next Steps
“CRS patients who remain symptomatic after surgery represent one of the hardest-to-treat groups for ENTs,” said Chris Marich, MBA, Chief Executive Officer of Oticara. “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.”
Following these promising findings, Oticara is preparing for additional clinical trials to further evaluate the efficacy, durability, and long-term safety of its nasal steroid cream. The company’s next-phase studies will explore broader patient populations and may assess repeated dosing regimens to determine optimal treatment strategies for chronic disease management.
Impact on Future ENT Practice
If confirmed in larger studies, Oticara’s therapy could become an important new option in the ENT treatment toolkit. Its in-office, single-application approach offers a practical and efficient solution for physicians while minimizing patient burden and reducing reliance on systemic steroids.
For patients, this could mean faster symptom relief, fewer repeat treatments, and improved overall quality of life. For clinicians, it represents a seamless integration into existing practice workflows—a rare advantage in the current therapeutic landscape.
Publication and Future Outlook
The full data from the OT-007B Phase 2 trial have been submitted for publication in an upcoming special issue summarizing late-breaking presentations from the AAO-HNSF’s peer-reviewed journal.
With these encouraging results, Oticara continues to advance its mission to redefine CRS treatment through innovative, targeted, and safe therapies designed to improve the lives of patients with chronic sinus disease.
