January 24, 2017
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Ocular Therapeutix resubmits new drug application for Dextenza, announces public offering
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Ocular Therapeutix has resubmitted a new drug application to the FDA for Dextenza for treatment of ocular pain after ophthalmic surgery, according to a company press release.
Dextenza releases dexamethasone for up to 30 days after being placed through the punctum.
The NDA was resubmitted following a July 2016 complete response letter from the FDA identifying deficiencies in the company’s manufacturing process and controls, the release said.
A response to the NDA is expected within 30 days.
In a separate press release, Ocular Therapeutix announced it will be offering $25 million of shares of its common stock.
The public offering price will be $7 per share, and the offering is expected to close on or about Jan. 27.