Intersect ENT has reported positive results from the Phase III RESOLVE II trial of its steroid releasing implant to facilitate a less invasive treatment procedure.
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The investigational RESOLVE steroid releasing implant is designed for patients with recurrent ethmoid sinus obstruction.
It releases mometasone furoate directly into the sinus lining to target inflammation.
The implant’s greater radial strength, unlike the PROPEL products, enables it to dilate an obstructed sinus and release steroid over a longer period of time thereby reducing inflammation.
The Phase III RESOLVE II randomised, blinded, multi-centre clinical trial is intended to evaluate the safety and efficacy of the RESOLVE steroid releasing implant.
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It evaluated 300 adult chronic sinusitis patients with the implant, all of whom were advised for revision sinus surgery at study entry due to recurrent symptoms and obstructive inflammation.
The patients were divided into two groups which were a treatment group consisting of bilateral RESOLVE implant placement and a group consisting of a sham procedure.
Results suggested the study meeting both the co-primary efficacy endpoints which were achieving a reduction in polyp grade and reduction in nasal obstruction and congestion.
Secondary endpoints were to minimise the requirement of repeat sinus surgery and improvements in sense of smell, sense of nasal obstruction, and total symptom score.
The implant also exhibited safety while being used during endoscopic examination and evaluation of adverse events.
Intersect ENT president and CEO Lisa Earnhardt said: “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.
“The RESOLVE product offers a less invasive and potentially more cost effective solution for this challenging patient population.”
The company is planning to submit New Drug Application (NDA) next year to secure the regulatory approval from the US Food and Drug Administration (FDA) for the Resolve product.
Image: Intersect ENT's RESOLVE steroid releasing implant. Photo: courtesy of Business Wire.
