Intersect ENT (NSDQ:XENT) said today that the FDA is slated to make a decision on its new drug application for the Sinuva steroid-releasing sinus implant by January 7, 2018.
The Sinuva implant, which was previously called the Resolve implant, is placed during an in-office doctors appointment and is designed to be a treatment option for patients with recurrent ethmoid sinus obstruction. Traditionally, treatment for the condition includes high-dose oral steroids and repeat surgery.
“The SINUVA implant offers the potential to provide a less invasive and more cost-effective solution, performed easily in the doctor’s office, for patients suffering from persistent chronic sinusitis,” president & CEO Lisa Earnhardt said in prepared remarks. “We are excited that FDA’s filing of this NDA advances us a step closer to bringing this important innovation to ENT physicians and their patients.”
Sinuva is Intersect’s 4th steroid-releasing implant. The device was assessed in 4 clinical trials to evaluate safety and efficacy.
Resolve II, the company’s pivotal study, examined the implant in 300 adult chronic sinusitis patients who were indicated for revision sinus surgery at the start of the study.
Patients were randomized into 2 groups – a treatment group that received bilateral Sinuva implant placement and a control group that received a sham procedure. Both groups of participants continued to receive standard treatments, including topical nasal steroid sprays.
The trial met both co-primary efficacy endpoints, according to Intersect ENT, and demonstrated a statistically significant reduction in nasal congestion and polyp burden. The trial also met its secondary endpoints, including a reduction in the proportion of patients still indicated for repeat sinus surgery and improvements in nasal obstruction symptoms and sense of smell.
XENT shares were trading at $23.10 apiece in mid-afternoon activity today, up +1.5%.