Ocular Therapeutix (NSDQ:OCUL) said today that it submitted details of a manufacturing equipment change as an amendment to the new drug application resubmission for Dextenza, the company’s dexamethasone insert that is currently under review by the FDA.
The FDA is slated to make a decision about the product’s regulatory approval by July 19. But the company recently revealed that the FDA issued a Form 483 to Ocular following a pre-approval inspection of a manufacturing facility, which detailed a number of issues relating to the manufacture of Dextenza.
According to the amendment, Ocular has made changes to the piece of manufacturing equipment referenced in the NDA resubmission and plans to submit data from a new commercial batch to show that the modification addresses the FDA’s concerns regarding “particulate matter”.
““We believe that the recent submission of our close-out response to the Form 483 and subsequent submission of the amendment to our NDA resubmission for FDA’s consideration can support an acceptable regulatory pathway for the approval of Dextenza,” president & CEO Amar Sawhney said in prepared remarks. “We continue to be in close communication with the FDA to determine the best course of action in an effort to successfully bring Dextenza to market.”
This isn’t the first time that the company has faced potential regulatory roadblocks thanks to manufacturing issues. In July last year, the FDA denied approval for Ocular’s hydrogel plug, Dextenza, after it discovered “deficiencies in manufacturing process and controls” in a pre-new drug application approval inspection.
A group of OCUL shareholders sued the company in New Jersey federal court last week, accusing it of not disclosing the manufacturing issues to investors.
The Bedford, Mass.-based company’s device is designed to deliver a sustained dosage of dexamethasone over 4 weeks following ophthalmic surgery.
Ocular has also experienced big changes to its personnel recently, including the planned departure of its president & CEO. Antony Mattessich was named president & CEO in place of Sawhney, effective Sept. 18.
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