MENLO PARK, Calif., Dec. 29, 2014 (GLOBE NEWSWIRE) -- Intersect ENT, Inc. (Nasdaq:XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced initiation of RESOLVE II, a pivotal Phase III clinical study to support U.S. Food and Drug Administration (FDA) approval of the company's RESOLVE steroid releasing implant designed to treat patients with recurrent sinus obstruction in the office setting.
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 Dr. 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, 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 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.
About Intersect ENT
Intersect ENT, Inc. is dedicated to improving the quality of life for patients with ear, nose and throat conditions. The company markets the first and only drug-releasing sinus implants, PROPEL and PROPEL mini, which are clinically proven to improve surgical outcomes for patients with chronic sinusitis. The products release an advanced steroid with anti-inflammatory properties directly into the sinus lining, then dissolve, maintaining the open passages created in ethmoid sinus surgery. In addition, Intersect ENT is pursuing clinical trials designed to support expanded indications and to assess two new investigational drug-eluting implants to provide ENT physicians with additional options to treat patients with chronic sinusitis less invasively and more cost effectively. Chronic sinusitis is an inflammatory condition leading to debilitating symptoms and chronic infections, and is one of the most costly conditions to U.S. employers. To learn more about Intersect ENT, please visit www.intersectENT.com.
Forward-Looking Statements
The statements in this press release that the RESOLVE steroid-eluting implant's ability to treat recurrent sinusitis, the impact on patients' quality of life and cost of care and that the implant may be further developed and approved by the FDA are "forward-looking" statements. These forward-looking statements are based on Intersect ENT's current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the short-term and long-term effects of the investigational product relative to alternative treatments may not be as Intersect ENT expects, the development of competitive products, the uncertain timing of completion of and the success of clinical trials, market competition, as well as other risks detailed from time to time in Intersect ENT's filings with the Securities and Exchange Commission, including its 10-Q filed on November 10, 2014. Intersect ENT does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.