RESOLVE II study of Sinuva, a steroid releasing sinus implant, is successful and FDA sets PDUFA date.- Intersect ENT.

Intersect ENT announced the first presentation of results from RESOLVE II, a randomized, double-blinded, controlled Phase III clinical trial, which assessed the safety and efficacy of Sinuva, an investigational steroid releasing sinus implant. The RESOLVE II pivotal study assessed the implant in 300 adult chronic sinusitis patients, all of whom were indicated for revision sinus surgery at study entry because of recurrent, medically refractory symptoms and bilateral nasal polyposis. Patients were randomized to either a treatment group, undergoing bilateral implant placement in the office setting, or a control group, undergoing a sham procedure. Both groups used mometasone furoate nasal spray once daily (200 mcg) through 90-day follow-up.

The study met the co-primary efficacy endpoints and four pre-specified secondary efficacy endpoints: Reduction in proportion of patients still indicated for repeat endoscopic sinus surgery at day 90: 39% of the treatment group vs. 63% of control (p=0.0004).Reduction in percent ethmoid sinus obstruction from baseline to day 90, as determined by the independent, blinded panel (p=0.0007). Reduction in nasal obstruction/congestion score from baseline to day 90 (p=0.0248). Improvement in decreased sense of smell score from baseline to day 90 (p=0.0470). Safety was evaluated by endoscopic examination and evaluation of adverse events. One serious implant-related adverse event, an intranasal bleed requiring intervention, was observed. The overall incidence of adverse events was similar between groups.

The company also announced in May 2017 that the FDA had set a PDUFA target action date for 7 January , 2018 for the SINUVA New Drug Application (NDA).