Ocular Therapeutix Inc
* Ocular Therapeutix™ receives complete response letter from fda for dextenza™ nda
* Ocular Therapeutix inc says outstanding items pertain to form fda-483 close-out of manufacturing deficiencies and analytical testing
* Ocular Therapeutix inc says complete response letter states that fda has determined that it cannot approve nda in its present form
* Ocular Therapeutix -crl acknowledges receipt of co's nda amendment dated july 10, 2017 and states amendment was not reviewed prior to fda's action of crl
* Ocular Therapeutix Inc says as a result, fda did not have opportunity to review company's close-out response prior to issuing crl
* Ocular Therapeutix -FDA indicated applicable sections of amendment submitted by ocular could be incorporated when responding to deficiencies noted in crl
* Ocular Therapeutix Inc says satisfactory resolution of manufacturing deficiencies detailed in form fda-483 is required before nda may be approved
* Ocular Therapeutix -fda's letter did not identify any efficacy or safety concerns with respect to clinical data for dextenza provided in nda
* Ocular Therapeutix -fda's letter did not identify any need for additional clinical trials for nda approval Source text for Eikon: Further company coverage:
