Intersect ENT has commercially introduced its Sinuva (mometasone furoate) Sinus Implant for the treatment of adults with nasal polyp disease in the US.
Intended for patients who have previously undergone ethmoid sinus surgery, Sinuva can be implanted in a standard physician’s office under local or topical anaesthesia.
After placement into the sinus cavity, the implant delivers an anti-inflammatory steroid directly to the diseased site over a long-term period of up to 90 days.
In various clinical studies, Sinuva is reported to have decreased polyps and nasal congestion symptoms, and less than 50% were observed to require repeat sinus surgery after its implantation.
Intersect ENT president and CEO Lisa Earnhardt said: “After years of development and multiple clinical studies, we are thrilled to provide physicians with Sinuva to treat patients with nasal polyps.
“Sinuva offers an alternative to patients who have exhausted routine medical management who don’t want to return to the operating room for a repeat surgery.
“We are introducing Sinuva through a targeted launch, working to build success through positive initial adoption and positioning Sinuva for the long-term growth we believe is achievable.”
During a pivotal RESOLVE II clinical trial involving 300 subjects, Sinuva demonstrated statistically significant decrease in bilateral polyp grade and nasal obstruction/congestion score.
The trial also met four out of the five pre-specified secondary endpoints. It did this by achieving a reduction in ethmoid sinus obstruction percentage, nasal obstruction/congestion symptoms and proportion of patients still indicated for sinus surgery and a better sense of smell.