Supplemental NDA for Dextenza for ocular itching submitted
Ocular Therapeutix has submitted a supplemental new drug application for Dextenza as a treatment for ocular itching associated with allergic conjunctivitis, according to a press release.
The dexamethasone ophthalmic insert 0.4 mg is already approved for intracanalicular use for treatment of postoperative ocular pain and inflammation.
A pooled analysis of four vehicle-controlled clinical trials including 323 subjects with ocular allergies and positive skin test reaction to perennial and seasonal allergens demonstrated lower ocular mean itching scores for Dextenza relative to placebo vehicle with a favorable safety profile, according to the release.
“As Dextenza is physician-administered and can’t be overused by patients, it provides a potentially safer method of steroid delivery,” Michael Goldstein, MD, MBA, chief medical officer of Ocular Therapeutix, said in the release.
Furthermore, the preservative-free treatment could benefit these patients with an already compromised ocular surface, he said.
If approved, the supplemental NDA would be the first indication for Dextenza treatment primarily in the ophthalmology office setting, Antony Mattessich, president and CEO of Ocular Therapeutix, said in the release.
An October 2021 PDUFA date is anticipated.
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