Oticara’s Novel Steroid Nasal Cream Shows Promising Phase 2 Results in Post-Surgical Chronic Rhinosinusitis Patients
Oticara, a clinical-stage pharmaceutical company focused on developing innovative therapies for chronic rhinosinusitis (CRS), announced highly encouraging Phase 2 results for its proprietary steroid nasal cream, OT-007B. The findings, presented as a late-breaking oral podium session at the American Academy of Otolaryngology – Head and Neck Surgery Foundation (AAO-HNSF) 2025 Annual Meeting & OTO EXPO℠ in Indianapolis, revealed significant and durable symptom improvements in patients suffering from persistent CRS symptoms following endoscopic sinus surgery (ESS).
The study results mark a pivotal moment in the treatment of chronic rhinosinusitis—a condition that remains notoriously difficult to manage even after surgical intervention. For patients who continue to experience nasal congestion, facial pain, and reduced sense of smell despite surgery, Oticara’s novel approach could redefine how otolaryngologists address ongoing inflammation and symptom recurrence.
Addressing a Critical Gap in Post-Surgical CRS Care
CRS affects millions of people globally and can significantly impair quality of life. For many patients, endoscopic sinus surgery (ESS) offers relief by improving sinus drainage and ventilation. However, a substantial subset—estimated at up to 20–30%—continue to suffer from inflammation and recurring symptoms despite surgical success. These patients often require prolonged courses of systemic corticosteroids or repeated topical therapies, both of which come with drawbacks such as limited efficacy or systemic side effects.
Oticara’s innovative steroid nasal cream seeks to close this therapeutic gap by combining precise, targeted steroid delivery with extended local retention on the nasal mucosa. The formulation is specifically optimized for mucosal adherence, ensuring that therapeutic concentrations remain in contact with inflamed tissue for days—unlike conventional nasal sprays or irrigations that are rapidly cleared from the sinuses.
According to Dr. Anders Cervin, MD, PhD, FRACS, the study’s senior author and presenter, the Phase 2 findings demonstrate the potential of Oticara’s approach to meaningfully alter ENT practice.
For ENTs, it is rare to see a therapy that can be delivered in-office in just minutes and still achieve such strong outcomes,” Dr. Cervin commented. “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.
Phase 2 Study Design and Objectives
The multicenter, open-label Phase 2 OT-007B trial enrolled 24 patients who continued to experience CRS symptoms despite undergoing prior ESS. Conducted across several U.S. centers, the study evaluated a single-dose, in-office application of Oticara’s proprietary steroid nasal cream. The cream, pre-filled in sterile syringes, was applied intranasally under endoscopic guidance by an Ear, Nose, and Throat (ENT) specialist. The design allowed for controlled and targeted placement of the medication directly onto the affected nasal mucosa.
The trial’s co-primary endpoints included improvement in:
- 4 Cardinal Symptom Score (4CSS) – measuring nasal obstruction, nasal discharge, facial pain/pressure, and sense of smell, and
- Sino-Nasal Outcome Test (SNOT-22) – a validated quality-of-life measure assessing symptom severity and functional impact.
Secondary endpoints assessed patient-reported outcomes, physician-assessed scores, and long-term symptom durability.
Key Efficacy Findings: Strong, Durable, and Rapid Improvements
The results exceeded expectations across multiple clinical measures:
- 4CSS: Patients experienced a mean reduction of -3.82 points (32.6% from baseline; p<0.0001) at week 3. Over half the participants (58.3%) met responder criteria, indicating clinically meaningful symptom improvement.
- SNOT-22: The score reductions exceeded the minimum clinically important difference (MCID) at weeks 3, 6, and 9. Mean decreases were -17.15 at week 3 (p<0.0001), -10.70 at week 6 (p=0.0019), and -10.49 at week 9 (p=0.0025), highlighting the durability of symptom relief over the study period.
- SNOT-22 Subdomains: Improvements were observed across all symptom domains, including nasal, ear/facial, sleep, and emotional aspects (p≤0.001 for all at week 3), underscoring the therapy’s comprehensive benefit.
- Patient-Reported Outcomes: An impressive 91.7% of patients reported feeling better on the Patient Global Impression of Severity (PGIS) scale, with many noting improved sense of smell—a symptom particularly resistant to treatment.
- Physician-Assessed Outcomes: Clinicians observed measurable improvement in the Modified Lund-Kennedy Score (MLKS), which evaluates mucosal edema and discharge, as well as reductions in nasal polyp burden, suggesting improved sinus health.
- Durability: Benefits were maintained through nine weeks, the full duration of follow-up, indicating lasting efficacy from a single in-office treatment.
Safety and Tolerability
Safety outcomes were notably favorable. The therapy was well tolerated across all patients, with no severe, serious, or fatal adverse events reported. Importantly, there were no clinically significant changes in intraocular pressure (IOP) or serum cortisol levels, metrics that serve as key indicators of systemic steroid exposure.
This finding is particularly relevant for CRS management, as long-term or systemic corticosteroid use often raises safety concerns such as adrenal suppression or ocular complications. By delivering strong local anti-inflammatory effects with minimal systemic absorption, Oticara’s nasal cream offers a potentially safer alternative to traditional systemic steroid regimens.
Pharmacokinetic Insights: Targeted Efficacy with Minimal Systemic Exposure
In pharmacokinetic analyses, Oticara’s formulation demonstrated that systemic exposure following a single intra-sinus application was roughly equivalent to that of a 10 mg oral prednisone dose—over 90% lower than a standard five-day oral corticosteroid course. Despite this minimal systemic absorption, patients achieved significant clinical improvement, indicating robust local therapeutic activity within the nasal mucosa.
This unique balance between potent localized effect and reduced systemic risk highlights the innovation behind Oticara’s nasal-mucosa-optimized cream platform. The formulation’s ability to adhere to inflamed mucosa and release active drug over an extended period may represent a meaningful advance in localized steroid therapy.
A New Paradigm for ENT Practice
According to Chris Marich, MBA, Chief Executive Officer of Oticara, these results underscore the company’s mission to transform how ENTs manage post-surgical CRS.
CRS patients who remain symptomatic after surgery represent one of the hardest-to-treat groups for ENTs,” Marich stated. “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.
Because the treatment can be applied in-office under endoscopic visualization, it fits naturally into ENT workflows, avoiding the need for additional surgeries or prolonged systemic medication use. For patients, the approach offers convenience, safety, and sustained relief with just a brief outpatient procedure.
Next Steps and Future Outlook
Encouraged by these Phase 2 findings, Oticara is preparing for further clinical trials to validate and expand upon these results in larger patient populations. Future studies may explore dosing optimization, repeated applications, and comparisons against standard-of-care treatments to solidify OT-007B’s role in post-surgical CRS management.
The company has also submitted the Phase 2 data for publication in the upcoming AAO-HNSF peer-reviewed journal, which will include a summary of late-breaking presentations from the 2025 Annual Meeting.
As Oticara advances its development pipeline, the company remains focused on its core mission—improving the quality of life for patients with chronic rhinosinusitis through precision-targeted, durable, and safe therapies.
