Ocular Therapeutix Gets Lead Product Back On Track
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.
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The latest drug development news and highlights from our US FDA Performance Tracker.
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.
The latest drug development news and highlights from our FDA Performance Tracker.