Dextenza (dexamethasone insert) refiled with FDA for ocular pain occurring after ophthalmic surgery- Ocular Therapeutix

Ocular Therapeutix has resubmitted a New Drug Application (NDA) to the FDA for Dextenza (dexamethasone insert) 0.4 mg, for the treatment of ocular pain occurring after ophthalmic surgery. Ocular Therapeutix resubmitted the NDA in response to a complete response letter (CRL) the Company received from the FDA in July 2016, which identified items pertaining to deficiencies in manufacturing process and controls. The Company expects to receive an indication of the scope and timing of the FDA�s review of the Company�s NDA resubmission within approximately 30 days.

The Company believes that the FDA review period of the NDA resubmission will be up to two months if a Class 1 (minor review) designation is received and up to six months if a Class 2 (major review) designation is received. Class 1 or 2 designation is dependent on whether an FDA re-inspection of the Ocular Therapeutix manufacturing facility will be a condition of NDA approval.

Comment: Dextenza is a product candidate administered by a physician as a bioresorbable intracanalicular insert and designed for drug release to the ocular surface for up to 30 days.