Ocular Therapeutix resubmits Dextenza to the FDA (for the third time).
What is Dextenza?
It’s a dexamethasone insert, placed through the punctum into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days. Following treatment, Dextenza resorbs and exits the nasolacrimal system without the need for removal. The trial investigated Dextenza for the treatment of post-surgical ocular inflammation and pain.
Why was it rejected previously?
Both the first and second submissions to the FDA were rejected because of concerns relating to the manufacturing process.
When will we hear if this is approved?
They company is hoping by the end of this year. (via)
