May 8, 2017 / 12:21 PM / in 3 months

BRIEF-Ocular Therapeutix presents additional phase 3 data results for Dextenza

1 Min Read

May 8 (Reuters) - Ocular Therapeutix Inc

* Ocular Therapeutix presents additional phase 3 data and patient reported outcomes results for Dextenza at the American Society of Cataract and Refractive Surgery (ASCRS) symposium

* Says U.S. FDA has set a target action date under prescription drug user fee act (PDUFA) of July 19, 2017

* There were no treatment-related serious adverse events (SAES) and Dextenza was well tolerated in all clinical trials

* PDUFA date of July 19, 2017 for decision regarding potential approval of Dextenza for treatment of ocular pain following ophthalmic surgery

* Subject to approval of NDA for post-surgical ocular pain by FDA, Ocular Therapeutix intends to submit supplement to NDA for Dextenza

* No patients experienced any adverse events resulting in study withdrawal Source text for Eikon: Further company coverage:

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