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Ocular Therapeutix's Dextenza successful in late-stage study in post-surgical ocular inflammation and pain; shares ahead 24% premarket

Published 11/14/2016, 07:47 AM
Ocular Therapeutix's Dextenza successful in late-stage study in post-surgical ocular inflammation and pain; shares ahead 24% premarket
OCUL
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  • Micro cap Ocular Therapeutix (NASDAQ:OCUL) is up 24% premarket on light volume in response to its announcement of successful results from a Phase 3 clinical trial assessing lead product candidate DEXTENZA (sustained release dexamethasone) Intracanalicular Depot for the treatment of post-surgical ocular inflammation and pain.
  • The 438-subject study met its two primary endpoints of statistically valid differences between the treatment group and placebo group in the absence of inflammatory cells at Day 14 and absence of pain on Day 8 (day of surgery was Day 1). Specifically, 52.3% of patients receiving DEXTENZA showed an absence of inflammatory cells in the anterior chamber of the study eye on Day 14 compared to 31.1% of those receiving placebo (vehicle control punctum plug)(p<0.0001). On Day 8, 79.6% of patients in the DEXTENZA cohort reported absence of pain in the study eye versus 61.3% for placebo (p<0.0001).
  • DEXTENZA is designed to deliver dexamethasone, a corticosteroid, to the ocular surface for four weeks. It is placed through the punctum (small opening), a natural opening in the eyelid, into the canaliculus (small channel in the eyelid) where it is resorbed over time.
  • The company's U.S. marketing application is currently under FDA review. The company received a Complete Response Letter (CRL) in July that Ocular is working through.
  • Management will host a conference call this morning at 8:30 am ET to discuss the results.

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