Massachusetts-based Ocular announced it had received a complete response letter last night, explaining that the US regulator raised concerns about manufacturing process and controls during an inspection of its plant in Bedford.
The firm said: “The FDA’s letter did not provide any details as to which manufacturing deficiencies identified during the facility inspection remain open since the last response submitted by the Company.”
It added that: “Satisfactory resolution of the manufacturing deficiencies identified during the FDA facility inspection is required before the NDA may be approved.”
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.
Ocular said the US Food and Drug Administration’s (FDA) concerns only relate to how the Dextenza is made and stressed the agency has neither raised questions about its safety nor asked for trials to be repeated.
News of the CRL comes a few weeks after Ocular signed the lease on a new manufacturing, R&D and office building. The building is located a few plots away from the firm's existing manufacturing site on Crosby Drive. in Bedford.
In a US Securities and Exchange Commission (SEC) filing dated June 17, Ocular said it intends “to relocate its corporate headquarters to the Premises beginning in 2017 and the Company intends to relocate all of its operations to the Premises by 2018."
FDA focus on eye drugs
The FDA has had its eye on ocular medication developers in recent months.
Last week the agency sent Valeant a CRL about its candidate ocular hypertension drug in which it raised concerns about manufacturing practices at a facility operated by contractor Bausch + Lomb in Tampa, Florida.
Valent has said it will address the FDA's concerns.