Intersect ENT's (XENT) Study of RESOLVE In-Office Steroid Releasing Implant Met Both Co-Primary Efficacy Endpoints
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Intersect ENT, Inc. (Nasdaq: XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced positive 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. Robert Kern, M.D., of Northwestern University and Pablo Stolovitzky, M.D., of ENT of Georgia served as national co-principal investigators of the study.Placed during a routine physician office visit, the RESOLVE steroid releasing implant is designed to provide a less invasive treatment option for patients with recurrent ethmoid sinus obstruction that might otherwise warrant a repeat surgical procedure.
Both Primary Efficacy Endpoints Achieved
The study met both co-primary efficacy endpoints:
- Reduction in Polyp Grade. 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 (p=0.007) difference in mean change from baseline favoring the treatment group was observed.
- Reduction in Sense of Nasal Obstruction and Congestion. 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 (p=0.007) 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.
Approximately 635,000 patients suffer from recurrent chronic sinusitis following sinus surgery each year. Patients with recurrent disease currently have limited treatment options, which include high-dose oral steroids and repeat surgery.
“The RESOLVE II study outcomes are compelling, and the medical community is eager to embrace new treatment options such as this less invasive procedure that can easily be performed in a physician’s office,” said Robert Kern, M.D., Chair of Otolaryngology – Head and Neck Surgery at Northwestern Medical Center. “The study results suggest that RESOLVE has the potential to improve quality of life while allowing patients to avoid additional surgical procedures.”
“This is a significant milestone in our history and for our future as we look to dramatically expand the impact we have across the continuum of care for sinusitis sufferers,” said Lisa Earnhardt, president and CEO of Intersect ENT. “The RESOLVE product offers a less invasive and potentially more cost effective solution for this challenging patient population. As part of our commitment to evidence-based innovation, we look forward to taking the next step toward bringing RESOLVE to ENT physicians and their patients.”
Intersect ENT plans to submit a New Drug Application (NDA) in the first quarter of 2017 for regulatory approval from the U.S. Food and Drug Administration (FDA) to market the RESOLVE product.
Six-month results from the original RESOLVE study demonstrated that control patients were at 3.6 times higher risk of remaining indicated for revision sinus surgery compared to patients receiving the RESOLVE implant. This study was published in the International Forum of Allergy and Rhinology journal in June 2016.
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