Ocular (OCUL) Gets FDA Nod For Label Expansion Of Dextenza
Zacks Investment Research | Jun 24, 2019 08:50AM ET
Ocular Therapeutix, Inc. (NASDAQ:OCUL) announced that the FDA approved a supplemental New Drug Application (sNDA) for Dextenza.
The drug is now approved for the treatment of ocular inflammation following ophthalmic surgery as an additional indication.
We remind investors that the FDA approved the company’s new drug application (NDA) for Dextenza for intracanalicular use to treat ocular pain post ophthalmic surgery last December.
With this upside, Dextenza is now approved for the treatment of both ocular inflammation and pain after ophthalmic surgery.
The approval of the sNDA was supported by three phase III randomized, vehicle-controlled studies wherein patients received Dextenza or a vehicle immediately upon completion of cataract surgery. Results showed that treatment with Dextenza had a higher proportion of patients, who were pain free on post-operative Day 8 than the vehicle group.
Dextenza is also being evaluated for allergic conjunctivitis.
Shares of Ocular have rallied 11% year to date compared with the Original post
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