Ocular Therapeutix, Inc., has received a complete response letter from the FDA regarding its new drug application (NDA) for Dextenza (dexamethasone insert) 0.4 mg for intracanalicular use in the treatment of ocular pain after ophthalmic surgery.
The concerns raised by the FDA pertain to deficiencies in the manufacturing process and controls identified during a pre-NDA approval inspection of the Ocular Therapeutix manufacturing facility. The FDA’s letter did not provide details as to which manufacturing deficiencies identified during the facility inspection remain open since the last response submitted by the company.
Satisfactory resolution of the manufacturing deficiencies identified during the FDA facility inspection is required before the NDA can be approved. The FDA’s letter 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.
Inserted noninvasively through the punctum, the Dextenza plug resides within the canaliculus, delivering a four-week tapered release of corticosteroid to the ocular surface. After therapy is complete, the hydrogel resorbs and exits the nasolacrimal system without need for removal by the physician. Dextenza provides a dropless option for steroid therapy, according to the manufacturer.
A phase 2 study was conducted to evaluate the safety and efficacy of Dextenza after cataract extraction with intraocular lens implantation. The Dextenza group demonstrated superiority over placebo for the absence of pain at all time points (P < 0.005). The Dextenza group also showed 100% retention through day 14 and 97% retention through day 30. No long-term spikes in intraocular pressure were observed.
In addition, substantially more placebo-treated subjects were prescribed rescue medication (72%) compared with the Dextenza-treated subjects (21%) at days 14 and 30. Adverse events in the study eye were experienced by 43% of the placebo group compared with 14% of Dextenza group. The placebo-treated patients also experienced more corneal edema, photophobia, and bulbar conjunctival injection.