FDA reviewing Ocular's Dextenza for third time

Ocular Therapeutix Inc. (NASDAQ:OCUL) said FDA accepted for review a resubmitted NDA for Dextenza dexamethasone insert (sustained-release dexamethasone, OTX-DP) to treat ocular pain following ophthalmic surgery. The PDUFA data is Dec. 28.

Ocular has received two complete response letters from FDA for Dextenza, the first in July 2016 and the second in July 2017. The 2017 letter cited deficiencies in manufacturing processes and analytical testing, but did not identify any efficacy or safety concerns (see "Ocular Receives Second CRL for Dextenza")...