Intersect ENT, Inc. (NASDAQ: XENT), a company dedicated to transforming care for patients with ear, nose and throat conditions, today announced U.S. commercial availability of the SINUVA™ (mometasone furoate) Sinus Implant, a new
Placed during a routine doctor’s office visit under local or topical anesthesia, SINUVA is designed to deliver an anti-inflammatory steroid directly to the site of disease for an extended period of time (up to 90 days) following placement into the sinus cavity. SINUVA is clinically proven to reduce polyps and symptoms of nasal congestion. In addition, in a study of patients indicated for repeat sinus surgery, less than half of patients still needed surgery following placement of the SINUVA implant.
“Recurrent nasal polyposis is one of the most challenging conditions for ENT physicians. Many sufferers return to their ENT physician despite sinus surgery due to recurrence of symptoms,” said Satish Govindaraj, M.D., associate professor and vice chairman of Clinical Affairs in the Department of Otolaryngology of Mount Sinai Medical Center, one of the clinical trial sites involved in the pivotal study of SINUVA. “The clinical data supporting the use of the SINUVA implant is compelling. I believe this innovative treatment option will be attractive for many of my patients.”
Nasal polyps are inflammatory growths along the lining of nasal passages or sinuses that can cause nasal congestion, infections and loss of sense of smell. Approximately 635,000 Americans have had previous sinus surgery and continue to see their ENT physicians for treatment of recurring symptoms.
“After years of development and multiple clinical studies, we are thrilled to provide physicians with SINUVA to treat patients with nasal polyps. SINUVA offers an alternative to patients who have exhausted routine medical management who don’t want to return to the operating room for a repeat surgery,” said Lisa Earnhardt, president and CEO of Intersect ENT. “We are introducing SINUVA through a targeted launch, working to build success through positive initial adoption and positioning SINUVA for the long-term growth we believe is achievable.”
“Steroid releasing implants have been a mainstay of my treatment for patients following sinus surgery. SINUVA represents a related technology uniquely designed for patients who continue to struggle with nasal polyps,” said Greg Davis, M.D., M.P.H., associate professor of otolaryngology-head and neck surgery at the University of Washington School of Medicine in Seattle. He was among the first in the United States to utilize the SINUVA product. “The SINUVA implant delivers steroids in a time-released fashion right to the source where we need it, in a simple office procedure.”
The efficacy of the SINUVA Sinus Implant was demonstrated in the landmark RESOLVE II pivotal study in 300 patients who were indicated for repeat sinus surgery. RESOLVE II met both co-primary efficacy endpoints as patients receiving SINUVA experienced (1) a statistically significant reduction from baseline to 90 days in bilateral polyp grade (p=0.007), which corresponded to 74% relative reduction in the extent of ethmoid polyp disease; and (2) a significant reduction from baseline to 30 days in nasal obstruction/congestion score (p=0.007), which corresponded to 30% relative improvement, compared to controls. Four of the five pre-specified secondary endpoints achieved statistical significance through day 90 favoring the SINUVA group, including reduction in percent ethmoid sinus obstruction, reduction of nasal obstruction/congestion symptoms, improvement in sense of smell, and reduction in the proportion of patients still indicated for repeat sinus surgery.
About Steroid Releasing Sinus Implants Steroid releasing implants provide targeted delivery of an anti-inflammatory steroid directly to the site of disease. The use of PROPEL® steroid releasing sinus implants, which are utilized following a surgical procedure to maintain the opening of the sinus passages, has been proven to reduce the likelihood that patients will need additional surgical interventions or require high-dose oral steroids. Placed during a routine doctor’s office visit with local or topical anesthesia, the SINUVA™ (mometasone furoate) Sinus Implant is designed to deliver a treatment for nasal polyp disease for adults who have had prior ethmoid sinus surgery. The American Rhinologic Society (ARS) endorsed the utilization of drug eluting sinus implants in 2016, citing the number of well-controlled studies on drug-eluting implants in the paranasal sinuses.