Ocular Therapeutix announced the FDA has accepted the filing of the supplemental new drug application (sNDA) for Dextenza (dexamethasone ophthalmic insert) to include the treatment of ocular inflammation following ophthalmic surgery in its label. The notice of acceptance confirms the FDA has completed its initial review of the filing and has determined that the sNDA is sufficiently complete to permit formal review.
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of November 10, 2019 for its review of the sNDA.
Dextenza is the first FDA-approved intracanalicular insert delivering dexamethasone to treat post-surgical ocular pain for up to 30 days with a single administration. Dextenza received FDA approval in November 2018 for the treatment of ocular pain following ophthalmic surgery. Dextenza is a resorbable, preservative-free ophthalmic insert that is placed in the lower lacrimal punctum and into the canaliculus of the eye.
The sNDA application to include inflammation [following ophthalmic surgery] is supported by the two phase 3 clinical trials used to obtain the pain approval and safety and efficacy data from a third prospective, multicenter, randomized, controlled phase 3 clinical trial of Dextenza (n=438) in cataract surgery patients that demonstrated statistical significance compared to the vehicle control for the endpoints of absence of ocular pain (P<0.0001) and absence of inflammation (P<0.0001). The ocular safety profile was similar to that demonstrated in the two prior phase 3 clinical trials. Data from the third phase 3 clinical trial was recently published in the Journal of Cataract & Refractive Surgery (JCRS) in February 2019.