Ocular Therapeutix tumbles on further FDA delay for Dextenza

US ophthalmic specialist Ocular Therapeutix (Nasdaq: OCUL) says it received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its resubmission of a New Drug Application (NDA) for Dextenza (dexamethasone insert) 0.4mg for the treatment of ocular pain following ophthalmic surgery.

The CRL states that the FDA has determined that it cannot approve the NDA in its present form. This is the second CRL as the FDA issued one in July 2016 which pointed to deficiencies in the company’s manufacturing processes and controls. The latest news led to a 32.2% fall to $7.60 in Ocular Therapeutix’ share price in post-market trading.

The latest CRL refers to deficiencies in manufacturing processes and analytical testing related to manufacture of drug product for commercial production identified during a pre-NDA approval inspection of the Ocular Therapeutix manufacturing facility that was completed in May 2017. As previously announced on July 10, the company submitted a response intended to close out all inspectional observations included in the Form FDA-483 issued in May 2017. The company also submitted details of a manufacturing equipment change on July 10, 2017 as an amendment to the NDA resubmission and requested that this be considered a major amendment that would extend the target action date under the Prescription Drug User Fee Act (PDUFA).