| 2016-10-17 08:03:02|
XENT 08:03 10/17 10/17/16
Intersect ENT reports RESOLVE II study met both primary efficacy endpoints
Intersect ENT announced results from RESOLVE II, a randomized, blinded, multi-center clinical trial designed to assess the safety and efficacy of the company's investigational RESOLVE steroid releasing implant. The RESOLVE II pivotal phase III study evaluated the implant in 300 adult chronic sinusitis patients, all of whom were indicated for revision sinus surgery at study entry due to recurrent symptoms and obstructive inflammation. Patients were randomized to one of two groups: a treatment group consisting of bilateral RESOLVE implant placement in the office, or a control group consisting of a sham procedure. The study met both co-primary efficacy endpoints. An independent panel of surgeons blinded to treatment assignment evaluated the change in mean bilateral polyp grade from baseline to day 90 based on video endoscopies. A statistically significant difference in mean change from baseline favoring the treatment group was observed. The change in mean Nasal Obstruction/Congestion score was measured from baseline to day 30, as scored by patients using a daily diary. A statistically significant difference in mean change from baseline favoring the treatment group was observed. Secondary endpoints achieving statistical significance through day 90 include the proportion of patients still indicated for repeat sinus surgery and improvements in sense of smell, sense of nasal obstruction, and total symptom score. Safety was evaluated by endoscopic examination and evaluation of adverse events. One serious device-related adverse event, an intranasal bleed requiring intervention, was observed. Intersect ENT plans to submit a New Drug Application, or NDA, in the first quarter of 2017 for regulatory approval from the U.S. FDA to market the RESOLVE product.