Dextenza sustained-release dexamethasone regulatory update

Ocular said FDA notified the company that its corrective actions “appear” to address all but 1 issue raised by the agency in a July complete response letter for an NDA for Dextenza sustained-release dexamethasone to treat ocular pain following ophthalmic surgery. The biotech said FDA raised 10 manufacturing inspectional observations in a Form 483 letter, with the outstanding issue relating to the testing of an inert gas component. FDA also requested Ocular provide evidence “when migration to automatic integration of analytical testing is complete,” which is anticipated this quarter according to Ocular (see BioCentury, Aug. 1). ...