Intersect ENT announces FDA approval for SINUVA sinus implant
Intersect ENT (XENT) announced that it has received approval from the U.S. Food and Drug Administration for the SINUVA Sinus Implant, a new targeted approach to treating recurrent nasal polyp disease in patients who have had previous ethmoid sinus surgery.
Placed during a routine physician office visit, SINUVA expands into the sinus cavity and delivers an anti-inflammatory steroid directly to the site of polyp disease for 90 days.
Results from a randomized clinical trial demonstrated a 63% relative reduction in bilateral polyp grade for patients treated with SINUVA, compared to control.
The FDA submission for the SINUVA Implant was supported by the results of clinical studies of 400 patients, including the landmark RESOLVE II pivotal study.
RESOLVE II met its co-primary efficacy endpoints, which included a statistically significant reduction from baseline in bilateral polyp grade and a reduction from baseline Nasal Obstruction/Congestion score.
Secondary endpoints achieving statistical significance through day 90 include the proportion of patients still indicated for repeat sinus surgery and improvements in sense of smell, sense of nasal congestion and percent ethmoid sinus obstruction.
The FDA did not require any post-approval clinical trials.
XENT closed at $28.60.
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