Ocular (OCUL) Submits An SNDA For Eye Pain Drug Dextenza
Zacks Investment Research | Jan 10, 2019 10:32PM ET
Ocular Therapeutix, Inc. (NASDAQ:OCUL) announced that it has submitted a supplemental new drug application (sNDA) for Dextenza (dexamethasone ophthalmic insert) to the FDA. The company is looking to expand Dextenza’s label for the treatment of patients with ocular inflammation following ophthalmic surgery. The FDA will complete its review in the second half of 2019.
Dextenza received the FDA approval for post-surgical ocular pain during the fourth quarter of 2018. With this nod, the drug became the first FDA-approved intracanalicular insert that delivers dexamethasone for treating ocular pain post ophthalmic surgery for up to 30 days with a single administration.
Shares of Ocular were up 2.5% in after-hours trading after the announcement of this news. Meanwhile, the stock has lost 18.6% in the past year, narrower than the Zacks Investment Research
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