Ocular Therapeutix reported Monday that the FDA approved Dextenza (dexamethasone) for intracanalicular use for the treatment of ocular pain following ophthalmic surgery. The agency had rejected the therapy, which is inserted through the punctum into the canaliculus, in July last year after identifying deficiencies in manufacturing processes at one of the company's production sites.
CEO Antony Mattessich noted that the clearance came "soon after our pre-approval inspection and approximately one month ahead of the PDUFA date." The executive added that the approval "is a major external validation of the drug delivery technology platform," with Dextenza having also been rebuffed by the FDA in 2016 due to manufacturing issues.
The resubmitted filing seeking clearance of Dextenza was accepted by the FDA in July. Ocular noted that approval of Dextenza was backed by safety and efficacy data from two late-stage studies. Results unveiled last year showed that the therapy was associated with a significantly higher rate of absence of anterior chamber flare than placebo, while data also illustrated that a significantly higher proportion of patients in the Dextenza arm were pain-free eight days after cataract surgery versus placebo.
Ocular noted that Dextenza is the first FDA-approved intracanalicular insert delivering dexamethasone to treat post-surgical ocular pain for up to 30 days with a single administration.
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