Intersect ENT, a company dedicated to improving the quality of life for patients with ear, nose and throat conditions announced the completion of enrollment in RESOLVE II, the second of two Phase III clinical studies to support US Food and Drug Administration (FDA) approval of the company’s investigational RESOLVE steroid-releasing implant.
Publication of long-term clinical data from RESOLVE, the initial Phase III study of the product, in the International Forum of Allergy and Rhinology.
RESOLVE and RESOLVE II are both prospective, randomized, blinded, multi-center clinical trials conducted to study the use of the company’s investigational RESOLVE steroid-releasing implant, placed during a routine physician office visit.
The RESOLVE implant is designed to be a less-invasive alternative to treat patients with recurrent sinus obstruction, typically due to polyps, that would otherwise warrant revision surgery.
The RESOLVE implant is designed to reduce inflammation by releasing mometasone furoate, an advanced steroid with anti-inflammatory properties, directly into the sinus lining.
RESOLVE II is the final planned clinical trial to support the FDA approval of the RESOLVE steroid-releasing implant.
The study enrolled 300 patients at 34 U.S. centers. Robert Kern, M.D., of Northwestern University and Pablo Stolovitzky, M.D., of ENT of Georgia serve as co-principal investigators of the study.
Study endpoints include assessment of both patient-reported symptoms and objective endoscopic outcomes. Intersect ENT expects to announce preliminary topline data from RESOLVE II in the fourth quarter of 2016, following completion of the blinded treatment period.
Long-term data from RESOLVE, the initial Phase III clinical study of the product, was published in the International Forum of Allergy and Rhinology journal. The RESOLVE study demonstrated 100% implant placement success and no implant related serious adverse events.
Through six-month follow-up, treated patients experienced statistically significant improvement in symptom scores, ethmoid sinus obstruction and polyp grade, compared to control patients. In addition, control patients were at 3.6 times higher risk of remaining indicated for revision sinus surgery than treated patients.
"We are pleased with the positive results from the RESOLVE study, and that we’ve completed enrollment of the RESOLVE II pivotal study ahead of schedule," said Lisa Earnhardt, president and CEO of Intersect ENT. "We look forward to completing patient follow-up for RESOLVE II and seeking FDA approval of the product."
The investigational RESOLVE steroid-releasing implant is designed to be placed during a routine physician office visit to provide a less invasive treatment option for patients with recurrent ethmoid sinus obstruction, typically due to polyps, that would otherwise warrant revision surgery.
RESOLVE implant releases mometasone furoate directly into the sinus lining to target inflammation directly. It was designed with greater radial strength than the PROPEL products in order to dilate an obstructed sinus and releases steroid over a longer period of time to reduce inflammation.
The RESOLVE implant is investigational and is not available for commercial use.