Intersect ENT, Inc. (NASDAQ: XENT), announced presentation of a meta-analysis from two randomized studies evaluating the safety and efficacy of SINUVA™, an investigational steroid releasing sinus implant.
The two studies evaluated the sinus implant in patients with recurrent and medically refractory nasal polyps. Results of the meta-analysis were presented on Saturday, September 9 at the American Rhinologic Society (ARS) Annual Meeting in Chicago by J. Pablo Stolovitzky, M.D., of ENT of Georgia.
“The results of this meta-analysis affirm our excitement about the potential of the SINUVA implant, if approved, to improve care for patients who suffer from nasal obstruction and polyps with treatment via a less invasive solution,” said Lisa Earnhardt, president and CEO of Intersect ENT.
The safety and efficacy of SINUVA have been evaluated in four clinical studies. This meta-analysis was conducted on the pooled data from RESOLVE (n=100) and RESOLVE II (n=300), both prospective, randomized, controlled, blinded, multicenter clinical trials that enrolled adult chronic sinusitis patients who had undergone prior endoscopic sinus surgery.
The presented results of the meta-analysis, which was designed and conducted after the conclusion of RESOLVE and RESOLVE II, indicate that:
- Patients receiving implants experienced a statistically significantly greater improvement in nasal obstruction/congestion score from baseline to Day 90 compared to control (p=0.0176).
- Treatment patients experienced a statistically significantly greater reduction in bilateral polyp grade from baseline to Day 90 compared to control (p=0.0015).
- All study patients were candidates for revision sinus surgery at the study entry; 59% of treatment patients were no longer indicated for revision surgery at 90 days (p<0.0001).
- Overall adverse event rates were similar between the treatment and control groups. One serious implant-related adverse event, an intranasal bleed requiring intervention, was observed.
“The results of the 400-patient meta-analysis indicate that SINUVA may reduce clinical symptoms, polyp burden and the need for revision surgery,” said Dr. Stolovitzky. “The potential of an in-office solution backed by rigorous clinical evidence is exciting for ENTs managing this challenging patient population.”
In May 2017, the company announced that the U.S. Food and Drug Administration (FDA) had set a PDUFA target action date of January 7, 2018 for the company’s New Drug Application (NDA).
A copy of Dr. Stolovitzky’s presentation of the meta-analysis can be found on the “Investor Relations” page of the company’s web site at www.IntersectENT.com until September 15, 2017 and will be included in the company’s Form 8-K, to be filed on or about September 11, 2017.