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

Intersect ENT Inc., a company dedicated to transforming care for patients with ear, nose and throat conditions, announced publication of a pooled analysis of the RESOLVE and RESOLVE II randomized controlled trials (RCT). 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 percent reduction in the proportion of SINUVA patients who were still indicated for RESS at day 90 compared to a 31 percent reduction among patients in the control group (p<0.0001). Only one patient (0.4 percent) 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.”
 
SINUVA was approved by the U.S. Food and Drug Administration (FDA) in December 2017. Placed during a routine office visit under local or topical anesthesia, SINUVA is designed to deliver an anti-inflammatory steroid directly to the site of disease for an extended period of time (up to 90 days) following placement into the sinus cavity.
 
“We are very pleased to see these strong study findings added to the foundational pool of data supporting the use of SINUVA,” said Lisa Earnhardt, president and CEO, Intersect ENT. “We are proud that this data provides further evidence for ENTs seeking improved outcomes for patients with nasal polyps and supports SINUVA as a favorable alternative to revision endoscopic sinus surgery.”
 
RESOLVE was a double-blind RCT in 100 adult patients with chronic rhinosinusitis and nasal polyps, who had a previous sinus surgery and were indicated for revision endoscopic sinus surgery because they presented with recurrent nasal obstruction/congestion symptoms and recurrent bilateral sinus obstruction due to nasal polyps. The study evaluated the safety and efficacy of SINUVA to improve symptoms of nasal obstruction/congestion and reduce nasal polyps over three months. RESOLVE showed positive trends and an acceptable safety profile but did not meet its efficacy endpoints. The reduction in nasal obstruction/congestion score and bilateral polyp grade from baseline to day 90 reached statistical significance in a subset of patients with a higher polyp burden (grade 2 or higher on each side).
 
RESOLVE II was a double-blind RCT in 300 adult patients with chronic rhinosinusitis and nasal polyps who had a previous sinus surgery but were indicated for revision endoscopic sinus surgery because they presented with refractory symptoms of nasal obstruction/congestion and recurrent bilateral nasal polyps. The study evaluated the safety and efficacy of SINUVA over three months. Primary efficacy endpoints were a change in nasal obstruction/congestion score from baseline to 30 days and in bilateral polyp grade from baseline to 90 days. The SINUVA treatment group included 201 randomized patients who underwent bilateral placement of SINUVA in the ethmoid sinuses. Ninety-nine patients were randomized to the control group where they received a sham procedure. Patients receiving SINUVA demonstrated statistical improvements compared to the control group across multiple prespecified primary and secondary efficacy endpoints.
 
Steroid releasing implants provide targeted delivery of an anti-inflammatory steroid directly to the site of disease. Placed during a routine doctor’s office visit with local or topical anesthesia, the SINUVA (mometasone furoate) Sinus Implant is designed to deliver a treatment for nasal polyp disease for adults who have had prior ethmoid sinus surgery. The American Rhinologic Society (ARS) endorsed the utilization of drug eluting sinus implants in 2016, citing the number of well-controlled studies on drug-eluting implants in the paranasal sinuses.
 
Intersect ENT is dedicated to transforming ear, nose and throat care by providing clinically meaningful therapies to physicians and patients. The company’s steroid releasing implants are designed to provide mechanical spacing and deliver targeted therapy to the site of disease. In addition, Intersect ENT is continuing to expand its portfolio of products based on the company’s unique localized steroid releasing technology and is committed to broadening patient access to less invasive and more cost-effective care.
 
Intersect ENT is a registered trademark and SINUVA is a trademark of Intersect ENT Inc.