Ocular Therapeutix announced that it 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. 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.
“Following productive discussions with the FDA, we are pleased to announce the resubmission of our NDA for Dextenza for the treatment of ocular pain occurring after ophthalmic surgery,” Amar Sawhney, PhD, President, Chief Executive Officer and Chairman, said in a company news release. “If Dextenza is approved, we believe that its ability to provide a complete course of steroid therapy with one-time administration in the postsurgical setting will be extremely attractive for both ophthalmologists and patients. We continue to build our commercial organization and infrastructure in preparation for the earliest possible launch of Dextenza, subject to marketing approval.”
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 2 months if a Class 1 (minor review) designation is received and up to 6 months if a Class 2 (major review) designation is received. Class 1 or 2 designation is dependent on whether an FDA reinspection of the Ocular Therapeutix manufacturing facility will be a condition of NDA approval.
Dextenza (dexamethasone insert) 0.4mg is placed through the punctum, a natural opening in the eye lid, into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days. Following treatment, Dextenza resorbs and exits the nasolacrimal system without need for removal. The company has completed three phase 3 clinical trials with Dextenza for the treatment of postsurgical ocular inflammation and pain. Subject to the approval of the NDA for postsurgical ocular pain by the FDA, Ocular Therapeutix intends to submit an NDA supplement for Dextenza to broaden its label to include a postsurgical inflammation indication. Dextenza is also in phase 3 development for the treatment of ocular itching associated with allergic conjunctivitis.