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Manufacturing has for the second time stepped on Ocular Therapeutix’s chance of an FDA approval for its new drug for pain following eye surgery.
The Bedford, Massachusetts, biotech today said the FDA has issued it a second complete response letter after finding more issues at its manufacturing facility there. The CRL comes almost exactly a year after the FDA first nixed its approval chances for Dextenza because of manufacturing problems. Its share price fell 30% on the news.
Ocular Therapeutix CEO Amar Sawhney pointed out in a statement today that there no...