The studies evaluated Sinuva in patients with recurrent and medically refractory nasal polyps. The meta-analysis, which was presented at the American Rhinologic Society’s annual meeting, included data from the Resolve and Resolve II trials – both randomized, prospective clinical studies that enrolled adult chronic sinusitis patients who had undergone prior endoscopic sinus surgery.
“The results of this meta-analysis affirm our excitement about the potential of the Sinuva implant, if approved, to improve care for patients who suffer from nasal obstruction and polyps with treatment via a less invasive solution,” president & CEO Lisa Earnhardt said in prepared remarks.
The meta-analysis showed that patients receiving implants had a greater improvement in nasal obstruction/congestion score from baseline after 90 days compared to the control group.
The company also reported that patients with Sinuva had a greater reduction in bilateral polyp grade from baseline after 90 days compared to the control group.
All patients were candidates for revision sinus surgery at the start of the study and 59% of Sinuva patients were no longer indicated for revision surgery after 90 days, Intersect ENT said.
Adverse event rates were similar between the treatment and control groups, although the company observed one serious implant-related adverse event.
“The results of the 400-patient meta-analysis indicate that Sinuva may reduce clinical symptoms, polyp burden and the need for revision surgery,” Dr. Pablo Stolovitzky, CEO of ENT of Georgia, added. “The potential of an in-office solution backed by rigorous clinical evidence is exciting for ENTs managing this challenging patient population.”
The FDA is slated to make a decision regarding Intersect ENT’s new drug application for Sinuva by January next year.
XENT shares were trading at $32.95 in morning activity today, up 3.1%.