Intersect ENT (NSDQ:XENT) said today that it submitted a New Drug Application to the FDA for its Resolve steroid-releasing implant to treat chronic sinusitis patients with recurrent sinus obstruction.
The Menlo Park, Calif.-based company’s implant can be placed during a routine physician office visit and is designed to be a less invasive treatment option for recurrent ethmoid sinus obstructions, including polyps.
“This FDA submission for our 4th steroid releasing implant is a significant milestone for Intersect ENT as we look to provide innovative solutions for patients with this persistent form of chronic sinusitis,” president & CEO Lisa Earnhardt said in prepared remarks. “The Resolve implant offers the potential for a less invasive and potentially more cost effective solution that can be easily performed in the physician’s office.”
Researchers evaluated the Resolve implant in 4 clinical studies to assess the safety and effectiveness of the device. 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 Resolve 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.
At the start of March, shares in Intersect ENT fell slightly even though the drug-device company met expectations on Wall Street with its 4th quarter results.
The company pared losses to -$4.8 million, or -17¢ per share, on sales of $24.2 million for the 3 months ended Dec. 31, for bottom-line growth of 15.8% on sales growth of 28.7% compared with the same period last year.
Adjusted to exclude 1-time items, earnings per share were -17¢, ahead of consensus on The Street, where analysts were looking for sales of $23.1 million.
The company won FDA approval for its Propel Contour steroid-releasing implant for the treatment of chronic sinusitis in the frontal and maxillary sinsuses at the end of February this year.
XENT shares were trading at $14.25 apiece in morning activity, up 1.1%.