Ocular Therapeutix provided an update on the status of its new drug application (NDA) for Dextenza (dexamethasone insert) 0.4 mg, for intracanalicular use in the treatment of ocular pain occurring after ophthalmic surgery. On July 25, 2016, Ocular Therapeutix announced that it received a complete response letter (CRL) from the FDA regarding its NDA for Dextenza that identified issues pertaining to deficiencies in the manufacturing process and controls identified during a pre-NDA approval inspection of the company’s manufacturing facility. The CRL for Dextenza did not identify any efficacy or safety concerns with respect to the clinical data provided in the NDA nor any need for additional clinical trials for the approval of the NDA.
Recently, the FDA issued a letter to Ocular Therapeutix noting that corrective actions detailed in its responses as a whole appear to address the ten inspectional observations raised in the Form FDA 483 with one exception which relates to the proposed process for identity testing of an incoming inert gas component used in the manufacturing process. In this letter, the FDA also requested that the company provide evidence (e.g., a final report) when migration to automatic integration of analytical testing is complete, which is anticipated during the third quarter of 2016.
“We are working closely with the FDA to address the one remaining item and are planning for a resubmission to our NDA as soon as possible,” Amar Sawhney, PhD, President, Chief Executive Officer, and Chairman, said in a company news release. “We remain committed to bringing Dextenza to market as rapidly as possible.”