Ocular Therapeutix (NSDQ:OCUL) said today that it resubmitted a New Drug Application to the FDA for its post-surgical ocular pain reliever. 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.
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