The Bedford, Mass.-based company noted that the resubmitted application aims to address manufacturing deficiencies highlighted by the FDA last year when the agency rejected Dextenza for the second time.
Ocular Therapeutix’s Dextenza device is designed to deliver a sustained dose of dexamethasone over four weeks following eye surgery, at which point it resorbs and exits the patient’s nasolacrimal system. The company is first pursuing a pain relief indication from the FDA, but has its sights set on inflammation and allergic conjunctivitis indications as well.
“We are pleased to announce the resubmission of the Dextenza NDA,” president & CEO Antony Mattessich said in prepared remarks. “Since last July, we have worked to make substantial improvements in our manufacturing processes and quality oversight that have allowed us to reach this important milestone.”
The company expects to hear back from the FDA by the end of this year, according to an SEC filing.
OCUL shares were trading at $6.84 apiece in mid-afternoon activity today, down -5.7%.