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

Oticara’s intranasal steroid cream met co-primary endpoints, demonstrating significant improvements in 4CSS and SNOT-22

Single in-office treatment delivered rapid, clinically meaningful benefits across patient- and physician-reported measures

AUSTIN, Texas--(BUSINESS WIRE)--Oticara, a clinical-stage pharmaceutical company developing therapies for chronic rhinosinusitis (CRS), today announced positive results from its Phase 2 OT-007B clinical trial evaluating the company’s proprietary nasal-mucosa-optimized steroid cream in patients with persistent CRS symptoms following endoscopic sinus surgery (ESS). Data were presented in 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.

“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.”

The multicenter, open-label Phase 2 study (n=24) evaluated a single-dose, in-office application of the intranasal cream supplied in pre-filled syringes and designed for precise, targeted delivery under endoscopic guidance by an Ear, Nose, and Throat (ENT) physician. The trial met its co-primary endpoints, demonstrating clinically meaningful and statistically significant improvements in both the 4 Cardinal Symptom Score (4CSS) and the Sino-Nasal Outcome Test (SNOT-22) at week 3, as well as significant benefits in several secondary endpoints, including patient-reported improvements in sense of smell.

• 4CSS: Mean reduction of -3.82 points (32.6% from baseline; p<0.0001) at week 3, with 58.3% of patients meeting responder criteria.

• SNOT-22: Exceeded the minimum clinically important difference (MCID) at week 3, week 6, and week 9. Scores reduced by -17.15 (p<0.0001) at week 3, -10.70 (p=0.0019) at week 6, and -10.49 (p=0.0025) at week 9.

• SNOT-22 subdomains: All subdomains improved significantly at week 3 (p≤0.001), and met their respective MCIDs.

• Patient-reported outcomes: 91.7% of patients reported improvement on the Patient Global Impression of Severity (PGIS), with clinically relevant gains in sense of smell.

• Physician-assessed outcomes: Improvements were observed by investigators in the Modified Lund-Kennedy Score (MLKS) and nasal polyp burden.

• Long-term durability: Provided durable symptom relief out to nine weeks, the length of the study.

• Safety: The treatment was well tolerated, with no severe, serious, or fatal adverse events and no clinically significant changes in intraocular pressure (IOP) or serum cortisol levels.

Chris Marich, MBA, Chief Executive Officer of Oticara, added: “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.”

Oticara improves steroid delivery in CRS with a physician-applied, targeted treatment that stays in place for days. Pharmacokinetic analysis demonstrated that systemic steroid exposure after 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 achieving strong local therapeutic benefit. The company is advancing preparations for additional clinical trials.

Data from this study has been submitted for publication in an upcoming summary issue of late-breaking presentations in the American Academy of Otolaryngology – Head and Neck Surgery Foundation’s peer-reviewed journal.

About Oticara
Oticara is an emerging, clinical-stage pharmaceutical company developing innovative therapies to improve the quality of life for patients with chronic inflammatory sinus conditions. The company’s lead product is the only sterilizable, nasal-mucosa-optimized steroid cream, administered by Ear, Nose, and Throat (ENT) physicians via a custom applicator. This patient-friendly, single-dose in-office therapy is being studied to deliver lasting relief for chronic rhinosinusitis (CRS) patients, while significantly minimizing systemic steroid exposure. Clinical studies have demonstrated rapid and sustained symptom improvement, even amongst patients whose symptoms have not been controlled by available therapies. With an initial focus on post-surgical CRS patients, Oticara is advancing a new treatment option for one of the most difficult-to-treat populations in ENT. Learn more at oticara.com.