FDA Denies Ocular Therapeutix’s Dextenza Over Controls

July 29, 2016

The FDA rejected Ocular Therapeutix’s candidate for post-surgery eye pain Dextenza due to manufacturing deficiencies.

In a complete response letter refusing the company’s NDA submission, the agency noted that an inspection had turned up flaws in Dextenza’s manufacturing processes and controls. According to the company, the letter does not specify which deficiencies prompted the rejection.

The company said it previously had responded to the agency’s complaints after receiving a Form 483 in February 2016. It’s anticipating an agency review of its updated manufacturing practices.

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