Intersect ENT Announces Publication of a Pooled Analysis of the SINUVA Sinus Implant for Nasal Polyps - Seite 2

Intersect ENT will sponsor several events at RhinoWorld Chicago from June 5 to 9. To learn more about SINUVA, visit Booth #18.

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.”

About the RESOLVE Study

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).

About the RESOLVE II Study

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.