Phase 3 Study Evaluating Safety and Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
Phase of Trial: Phase III
Latest Information Update: 21 Jun 2019
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At a glance
- Drugs Dexamethasone (Primary)
- Indications Ocular inflammation; Ocular pain
- Focus Registrational; Therapeutic Use
- Sponsors Ocular Therapeutix
- 21 Jun 2019 According to an Ocular Therapeutix media release, the U.S. Food and Drug Administration (FDA) approved a Supplemental New Drug Application (sNDA) for DEXTENZA to include the treatment of ocular inflammation following ophthalmic surgery as an additional indication. The approval of the sNDA is supported by three Phase 3 randomized trials.
- 02 Apr 2019 According to an Ocular Therapeutix media release, the notice of acceptance confirms that 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 10th Nov 2019 for its review of the sNDA.
- 02 Apr 2019 According to an Ocular Therapeutix media release, based on the data from two phase 3 trials (NCT02034019 and NCT02089113) used to obtain the pain approval and a third phase 3 trial of DEXTENZA (n=438; NCT02736175) in cataract surgery patients, the U.S. FDA has accepted for filing the sNDA for DEXTENZA to include the treatment of ocular inflammation following ophthalmic surgery in its label.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History