Data from Pharmawand - Curated by EPG Health - Date added 11 January 2019
Ocular Therapeutix announced the submission of a supplemental New Drug Application (sNDA) to the FDA for Dextenza (dexamethasone ophthalmic insert). The sNDA filing seeks to expand the current indication for Dextenza to include the treatment of ocular inflammation following ophthalmic surgery. The Company expects that the FDA review will be completed in the second half of 2019.
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 is supported by the two previous Phase III clinical trials and safety and efficacy data from an additional prospective, multicenter, randomized, controlled Phase III 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 III clinical trials. Data from the third Phase III clinical trial were recently published in the Journal of Cataract & Refractive Surgery (JCRS) in October 2018.0>