After on Monday submitting an amendment request to extend the review of its DEXTENZA new drug application, shares of biopharmaceutical Ocular Therapeutix (OCUL 6.01, -1.59) trade 20.9% lower after it today received a complete response letter from the US FDA.
A bit of background on DEXTENZA: DEXTENZA is placed through the punctum, a natural opening in the eye lid, into the canaliculus and is designed to deliver dexamethasone without preservatives to the ocular surface for up to 30 days. Following treatment, DEXTENZA resorbs and exits the nasolacrimal system without need for removal.
In short, the CRL holds that the FDA cannot approve the NDA in its present form. The CRL from the FDA 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.
Satisfactory resolution of the manufacturing deficiencies detailed in the Form FDA-483 is required before the NDA may be approved. The FDA’s letter did not identify any efficacy or safety concerns with respect to the clinical data for DEXTENZA provided in the NDA nor any need for additional clinical trials for the NDA approval.
As previously announced on Monday, OCUL 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 Monday 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).
The CRL acknowledges receipt of the company’s NDA amendment dated July 10, 2017 and states that the amendment was not reviewed prior to the FDA’s action of the CRL. As a result, the FDA did not have the opportunity to review the company’s close-out response prior to issuing the CRL. In addition, as noted in the CRL, the FDA indicated that applicable sections of the amendment submitted by OCUL could be incorporated when responding to deficiencies noted in the CRL.
Following an up and down past couple of days, shares made nearly eight month lows this morning. The stock has come off those levels, however, as bulls rush from the sidelines. Given the FDA made its decision prior to receiving the amendment from OCUL, it’s possible that the street is realizing the timing discrepancy a tad late and adjusting the gap lower accordingly.