Ocular Therapeutics resubmits Dextenza NDA, addresses FDA concerns

24 January 2017

USA-based biotech firm Ocular Therapeutix (Nasdaq: OCUL) has confirmed that a New Drug Application (NDA) for Dextenza (dexamethasone) has been re-submitted to the US Food and Drug Administration.

The company announced its intention to submit an NDA at the start of the year, on the back of strong Phase III trial data. The submission will address a complete response letter (CRL) received from the FDA in July 2016, which pointed to deficiencies in the company’s manufacturing processes and controls.

The review is expected to take either up to two months or six months, depending on whether the FDA determines that a re-inspection of Ocular’s manufacturing facilities is necessary. The company expects to receive clarity on this point within a month.

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