FDA Broadens Dextenza to Include Ocular Itching

FDA has approved an Ocular Therapeutix supplemental NDA to broaden Dextenza’s (dexamethasone ophthalmic insert) label to add an additional indication for treating ocular itching associated with allergic conjunctivitis. Previously the corticosteroid was approved for treating ocular pain and inflammation following ophthalmic surgery.

The new approval was based on data from three randomized, multicenter studies in subjects with a positive history of ocular allergies and positive skin test reaction to perennial and seasonal allergens. “In all three trials, Dextenza demonstrated lower mean ocular itching scores compared with the vehicle group at all time points throughout the study duration of up to 30 days,” the company says. The most common ocular adverse events seen in the studies were: increased intraocular pressure (3%), increased lacrimation (1%), eye discharge (1%) and reduced visual acuity (1%).