Ocular Therapeutix requests NDA extension for Dextenza

Ocular Therapeutix has submitted an amendment to its FDA new drug application resubmission for Dextenza, detailing a manufacturing equipment change, according to a company press release.The company has modified a piece of equipment referenced in its NDA resubmission and will submit data on a new commercial batch to show that the change has addressed issues regarding particulate matter, the release said.

Full Story →