FDA accepts supplemental NDA for Dextenza for ocular itching
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The FDA has accepted a supplemental new drug application for Dextenza for the treatment of ocular itching associated with allergic conjunctivitis, according to a press release from Ocular Therapeutix.
“The use of topical steroids is an important part of the clinical armamentarium in the treatment of a patient with allergic conjunctivitis, and if approved for this new proposed use, Dextenza could provide an office-based, physician-administered, preservative-free method of steroid delivery that benefits patients with ocular itching associated with allergic conjunctivitis,” Patricia Kitchen, chief operating officer of Ocular Therapeutix, said in the release.
The FDA set a PDUFA action date of Oct. 18, the release said.
Ocular Therapeutix submitted the supplemental NDA for Dextenza (dexamethasone ophthalmic insert 0.4 mg) in December. The drug is already approved to treat ocular inflammation and pain after ophthalmic surgery.
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