Intersect ENT Announces Publication of a Pooled Analysis of the SINUVA Sinus Implant for Nasal Polyps

Intersect ENT, Inc. (NASDAQ: XENT), a company dedicated to transforming care for patients with ear, nose and throat conditions, today announced publication of a pooled analysis of the RESOLVE and RESOLVE II randomized controlled trials (RCT) in the American Journal of Rhinology & Allergy. The results provide level 1a clinical evidence supporting the use of the SINUVA (mometasone furoate) Sinus Implant for management of patients with recurrent nasal polyps in adult patients who have had previous ethmoid sinus surgery.

The analysis included 375 patients with chronic sinusitis and nasal polyps who were candidates for revision endoscopic sinus surgery (RESS) because of persisting symptoms of nasal obstruction/congestion and recurrent bilateral nasal polyps (non-cancerous tissue growth) despite ongoing topical steroid therapy and a recent course of systemic steroids. Patients were randomized to undergo an in-office bilateral placement of SINUVA in the ethmoid sinuses under local anesthesia (treatment group) or an in-office bilateral sham procedure (control group). All patients were required to use mometasone furoate nasal spray (MFNS) once daily. All study patients were blinded during the baseline procedure and each follow-up endoscopic examination.

The pooled analysis met all four efficacy endpoints, demonstrating a decrease in nasal obstruction/congestion score (p=0.0095), bilateral polyp grade (p=0.0008) and ethmoid sinus obstruction (p<0.0001) at 90 days in SINUVA patients compared to the control group on MFNS alone. Additionally, results revealed a 59% reduction in the proportion of SINUVA patients who were still indicated for RESS at day 90 compared to a 31% reduction among patients in the control group (p<0.0001). Only one patient (0.4%) experienced an implant-related serious adverse event (epistaxis).

“The findings of this analysis reveal the favorable role SINUVA can play in the management of recurrent nasal polyps in patients who have had a previous sinus surgery,” said Pablo Stolovitzky, M.D., of ENT of Georgia in Atlanta, lead author of the study. “These data provide clinical evidence that SINUVA – administered through a quick and simple office procedure – offers significant benefits for patients, reducing polyp growth and nasal obstruction, and ultimately, reducing the need for repeat surgeries.”