Dextenza receives FDA approval for ocular itching associated with allergic conjunctivitis
The FDA has approved a supplemental new drug application for Dextenza, adding ocular itching associated with allergic conjunctivitis to the drug’s current indications, according to a press release from Ocular Therapeutix.
“Allergic conjunctivitis is a common condition seen in the offices of eye care providers. We are really excited about this label expansion and the potential benefits for patients,” Michael Goldstein, MD, president, ophthalmology, and chief medical officer at Ocular Therapeutix, said in the release.
The new approval for Dextenza (dexamethasone ophthalmic insert 0.4 mg) is based on three randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies that demonstrated lower mean ocular itching scores with Dextenza vs. vehicle at all time points throughout the study up to 30 days. In addition, the insert had a “favorable” safety profile.
Dextenza previously received FDA approval in 2018 for the treatment of ocular pain following ophthalmic surgery, with a label expansion to include the treatment of ocular inflammation following ophthalmic surgery in 2019.