Ocular Therapeutix (NSDQ:OCUL) said today that the FDA accepted the company’s resubmitted New Drug Application for its post-surgical ocular pain reliever, Dextenza. The hydrogel plug, inserted into a patient’s tear duct, is designed to deliver a sustained dose of dexamethasone over 4 weeks following opthalmic surgery.
The Bedford, Mass.-based company has had trouble gaining regulatory approval for the pain relief drug-device combo – in July last year, the FDA denied approval for Ocular’s Dextenza, citing concerns related to “deficiencies in manufacturing process and controls” which were identified during a pre-New Drug Application approval inspection of its manufacturing facility.
Get the full story at our sister site, Drug Delivery Business News.
The post FDA accepts Ocular’s NDA resubmission for Dextenza appeared first on MassDevice.
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