Now that Ocular Therapeutix Inc. has whiffed with a steel blade quick-fix to a particulates issue that delayed approval of its Dextenza (dexamethasone intracanalicular insert), the firm has a new CEO and a more measured plan for getting back into FDA's good graces.
Ocular's final closeout response to pre-approval inspection Form 483 findings, announced July 10, arrived at FDA too late to dissuade...