Does Ocular's Latest CRL Mean A Minor Delay For Dextenza, Or A New NDA?
The biotech sought a three-month action date extension with new manufacturing process data submitted to FDA just one day before the complete response letter.
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Ocular takes another swing at resolving the manufacturing issues that resulted in a complete response letter for its Dextenza.
The latest drug development news and highlights from our US FDA Performance Tracker.
The long-acting eye insert Dextenza has been accepted for review by the US FDA, a piece of good news for Ocular Therapeutix that had previously received a complete response letter on manufacturing issues and a mixed bag of late-stage clinical trial results.