The Phase III trial evaluated Sinuva in 300 adult chronic sinusitis patients, who were all indicated for revision sinus surgery at study entry due to recurrent, medically refractory symptoms and bilateral nasal polyposis.
Study participants were randomized to either receive the implant or a sham procedure. Both groups used mometasone furoate nasal spray once daily through 90 days.
The study met its co-primary efficacy endpoints and four secondary efficacy endpoints, the company reported. After 90 days, 39% of the treatment group was still indicated for repeat endoscopic sinus surgery, compared to 63% of the control group.
Patients in the treatment group also experienced a reduction in percent ethmoid sinus obstruction, reduction in nasal obstruction/congestion score and improvement in decreased sense of smell score compared to the control group after 90 days.
Intersect ENT said that researchers observed one serious implant-related adverse event during the trial – an intranasal bleed that required intervention.
In May, the company said that the FDA is set to make a decision about Sinuva’s new drug application by Jan. 7, 2018.