Ocular Therapeutix updates on Dextenza NDA, hopeful for resubmission

Ocular Therapeutix (NSDQ:OCUL) said today it received a complete response letter from the FDA covering the New Drug Application for Dextenza and updating that the company is hopeful it can resubmit the application “as soon as possible.”

Ocular Therapeutix’s Dextenza, formerly known as OTX-DP, is designed to deliver sustained dosage of dexamethasone over 4 weeks using a hydrogel plug inserted into a tear duct. The plug then dissolves and is flushed from the body as tears.

The Bedford, Mass.-based company said the agency identified “issues pertaining to deficiencies in the manufacturing process and controls identified during a pre-NDA approval inspection of the company’s manufacturing facility,” but did not identify any efficacy or safety concerns in the clinical data the company provided.

The FDA requested that Ocular Therapeutix provide evidence when ” migration to automatic integration of analytical testing is complete,” which the company expects to see during the 3rd quarter of 2016.

“We are working closely with the FDA to address the 1 remaining item and are planning for a resubmission to our NDA as soon as possible. We remain committed to bringing Dextenza to market as rapidly as possible,” CEO Amar Sawhney said in a press release.

Last week, Ocular Therapeutix received a complete response letter from the FDA denying approval for its Dextenza for an indication for treating ocular pain occurring after ophthalmic surgery.

The company said the FDA raised concerns related to “deficiencies in manufacturing process and controls” which were identified during a pre-New Drug Application approval inspection of its manufacturing facility.

Ocular Therapeutix said the FDA’s letter did not provide details as to which manufacturing deficiencies remain open since the company’s last response.

“We have previously responded to all requests in an effort to address the manufacturing items raised by the FDA during the application process, and we await completion of the review. Importantly, there were no clinical issues identified in the CRL pertaining to efficacy or safety related to the post-surgical pain indication. Labeling discussions with the FDA are ongoing. We remain optimistic that Dextenza will be approved once these open manufacturing items are closed. We will continue to work collaboratively with the FDA so they can finalize their review of our NDA, and are committed to bringing Dextenza to market as rapidly as possible,” CEO Amar Sawhney said in a press release.

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