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ARTICLE | Clinical News

Ocular receives second CRL for Dextenza

July 14, 2017 8:18 PM UTC

Ocular Therapeutix Inc. (NASDAQ:OCUL) said it received a second complete response letter from FDA for an NDA for Dextenza dexamethasone insert (sustained-release dexamethasone, OTX-DP) to treat ocular pain following ophthalmic surgery. Ocular said the letter refers to deficiencies in manufacturing processes and analytical testing, but did not identify any efficacy or safety concerns.

On July 10, Ocular submitted an amendment to the NDA with details of a manufacturing equipment change, but said FDA did not review the amendment prior to the latest CRL. The company said it is working with FDA to resolve the issues...

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