The resubmission included a letter from the US FDA’s New England District Office stating the firm had “satisfactorily addressed the remaining corrective actions in the Form 483 and manufacturing records from three recently completed commercial batches of Dextenza.”
A company spokeswoman told us the original observations related to "proposed processing for identity testing of an inert gas component used in the Dextenza manufacturing process."
She added that the fim has had "ongoing and productive communications with the FDA, including the district office, the Office of Process and Facilities within the Center for Drug Evaluation and Research or CDER, and an in person meeting with the FDA’s officers to discuss plans for the resubmission of the NDA.
The firm believes it has "taken all of the appropriate steps to address the manufacturing related items raised" the spokesperson continued.
The US FDA is expected to decide whether a re-inspection of Ocular Therapeutix's manufacturing facility in Bedford, Massachusetts is required in the next 30 days.
If an inspection is needed the process could take six months, while if a second visit is not deemed necessary the Dextenza review could begin in two months according to the firm.
Regulatory focus
Ocular Therapeutix has been trying to convince the agency to review Dextenza – a drug intended for the treatment of eye pain during surgery – since February when inspectors raised concerns about production process in a Form 483.
The 483 was followed in July by a Complete Response Letter (CRL) in which the FDA said it would not assess the drug until the problems were addressed.
Dextenza is a hydrogel-based dexamethasone depot. It is designed to be inserted into tear duct from where it delivers tapering doses of the corticosteroid to the ocular surface for a period of four weeks.
The product has shown superiority to placebo in the treatment of pain in patients who have undergone cataract surgery in a Phase II trial. It is currently being tested in a Phase III study.