Ocular Therapeutix Inc. resubmitted a new drug application to the U.S. FDA seeking approval of Dextenza for the treatment of ocular pain after ophthalmic surgery.
The agency declined to approve the drug in July 2016 due to deficiencies in manufacturing process and controls.
Ocular expects to receive an indication of the scope and timing of the FDA's review of the resubmission within about 30 days. It believes that the FDA review period of the resubmission will be up to two months if a class 1 designation is received and up to six months if a class 2 designation is received.
The designation depends on whether an FDA re-inspection of the Ocular manufacturing facility will be a condition of the approval of the application.