The FDA issued a complete response letter to Ocular Therapeutix denying its NDA for an ocular pain drug.
The agency cited problems with the manufacturing and analytical testing process for Dextenza (dexamethasone insert), a drug candidate for treatment of post-ophthalmic surgery ocular pain. FDA officials noted the issues in a May pre-NDA approval inspection of Ocular’s manufacturing facility.
The company responded to the observations from the inspection but the agency has not completed its review of the responses. Ocular also asked the agency to treat a manufacturing equipment change as a major amendment that made the company eligible for a target action date extension under PDUFA.