Intersect ENT Enrolls First Patient in Resolve II Trial

Menlo Park, Calif.-based Intersect ENT Inc. has enrolled the first patient in its phase II clinical study of its Resolve steroid releasing implant designed to treat patients with recurrent sinus obstruction. The study is meant to support U.S. Food and Drug Administration (FDA) approval of the device.

Resolve II is the final planned clinical trial of the Resolve steroid releasing implant, which is designed to provide an in-office treatment for patients who continue to suffer from chronic sinusitis despite previous sinus surgery. Current treatment options for these patients may include repeat surgery or systemic steroids. The Resolve bioabsorbable drug-eluting implant is placed in the ethmoid sinuses to provide an immediate opening of the sinus and reduce inflammation and polyps by releasing steroid locally for approximately three months.

The current study will enroll 300 patients at up to 45 U.S. centers. Robert Kern, M.D., of Northwestern University in Chicago, Ill. and Pablo Stolovitzky, M.D., of ENT of Georgia in Atlanta, Ga., serve as co-principal investigators of the study. Primary study endpoints include assessment of improvements through both patient-reported symptoms and objective endoscopic outcomes as determined by clinical investigators and by an independent panel of surgeons.

“For many patients, the chronic nature of the disease often results in recurrent symptoms requiring multiple surgeries and courses of oral steroids, which have been associated with possible detrimental side effects,” said Stolovitzky. “The Resolve in-office treatment has the potential to make a significant impact on patients’ quality of life and cost of care by reducing the need for revision surgeries. The Resolve II trial is designed to gather additional evidence of the safety and efficacy of the implant in the largest group of patients studied to date.”

“This study caps an exciting year for Intersect ENT. We are pleased to take another step forward in bringing another option to physicians and patients in the treatment of chronic sinusitis,” said Lisa Earnhardt, president and CEO of Intersect ENT.

The Resolve II study builds on the company’s recently completed Resolve clinical study. Similar in design, Resolve was a prospective, randomized, blinded, multi-center clinical trial that enrolled 100 patients. Resolve was designed to inform the design of the Resolve II study and provide safety and efficacy data to support the New Drug Application (NDA).

Like the company’s commercially available Propel and Propel mini implants used to improve surgical outcomes following sinus surgery, the investigational Resolve product releases mometasone furoate, an advanced steroid with anti-inflammatory properties, directly into the sinus lining to reduce inflammation. The Resolve product reportedly has more radial strength than the Propel products in order to dilate the obstructed sinus, and releases the steroid over a longer period of time.

Intersect ENT makes devices to treat ear, nose and throat conditions.