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# FDA 2nd ‘Complete Response’ on Eye Pain Insert
- URL: https://www.fdaweb.com/fda-2nd-complete-response-on-eye-pain-insert/
- Published: 2017-07-12T12:00:00.000Z
- Updated: 2026-09-14T22:33:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139117

FDA has issued a second complete response letter to Ocular Therapeutix on an NDA for Dextenza (dexamethasone insert) 0.4mg for treating ocular pain following ophthalmic surgery. The letter cites deficiencies in manufacturing processes and analytical testing related to manufacturing the drug product for commercial production identified during a pre-NDA approval inspection in May, according the company. In 7/2016, the first complete response letter was issued and raised concerns pertaining to unspecified deficiencies in the manufacturing process and controls section of the submission.

Ocular Therapeutix says it submitted 7/10 details of a manufacturing equipment change 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. However, FDA reportedly told the company in the latest letter that the amendment was not reviewed in time and it can be incorporated when responding to deficiencies noted in the letter. “Satisfactory resolution of the manufacturing deficiencies detailed in the Form FDA-483 is required before the NDA may be approved,” the company says.

  
Dextenza is designed to be placed through the punctum, a natural opening in the eyelid, into the canaliculus for delivering dexamethasone without preservatives to the ocular surface for up to 30 days. Following treatment, the insert resorbs and exits the nasolacrimal system without need for removal.