Dextenza NDA for Ocular Pain Submitted to the FDA
Ocular Therapeutix announced that it has submitted to the Food and Drug Administration (FDA) the New Drug Application (NDA) for Dextenza (sustained release dexamethasone) 0.4mg Intracanalicular Depot, for the treatment of ocular pain following ophthalmic surgery.
The NDA submission was based on results from two prospective, multicenter, randomized, parallel-arm, double-masked, vehicle-controlled Phase 3 trials conducted in 487 patients undergoing unilateral clear corneal cataract surgery in the first half of 2015. The co-primary efficacy endpoints were differences in the proportion of patients in the Dextenza group vs. the placebo group with absence of cells in the anterior chamber of the study eye, as measured using slit lamp examination, at Day 14 and absence of pain, as graded by a patient-reported score of 0 on a scale from 0–10, at Day 8.
Ocular Therapeutix intends to submit a supplemental NDA (sNDA) for the treatment of post-surgical inflammation, pending favorable results from its Phase 3 study. In addition, Dextenza is also under clinical investigation for other eye indications, such as, allergic conjunctivitis and inflammatory dry eye.
Dextenza (sustained release dexamethasone) 0.4mg Intracanalicular Depot is designed for a sustained delivery of corticosteroid to the ocular surface for four weeks.
For more information call (877) 628–8998 or visit OcuTx.com.