The Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Dextenza (dexamethasone ophthalmic insert; Ocular Therapeutix, Inc.) for the treatment of ocular inflammation following ophthalmic surgery.
The sNDA approval is supported by 3 randomized, double masked, vehicle controlled phase 3 trials in which patients received Dextenza or vehicle immediately following cataract surgery. Results showed a higher proportion of postoperative patients in the Dextenza group were pain free on day 8 and had a statistically significant absence of anterior chamber cells on day 14 compared with the vehicle group. Moreover, Dextenza demonstrated a statistical significance for the absence of ocular pain (P <.0001) and absence of inflammation (P <.0001) compared with the vehicle group, based on data from one of the phase 3 trials (N=438).
The most common treatment-related adverse reactions with Dextenza were anterior chamber inflammation including iritis and iridocyclitis (10%), increased intraocular pressure (6%), reduced visual acuity (2%), cystoid macular edema (1%), corneal edema (1%), eye pain (1%), conjunctival hyperemia (1%), and headache (1%).
“With our C-Code and pass-through payment status effective on July 1, the expanded indication gives us tremendous momentum as we approach our commercial launch,” said Antony Mattessich, the Company’s President and Chief Executive Officer.
Dextenza is already indicated for the treatment of ocular pain following ophthalmic surgery, receiving FDA approval in November 2018. Dextenza is an intracanalicular insert that delivers 0.4mg of dexamethasone for up to 30 days following insertion.
For more information visit dextenza.com.