A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase II Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery.
Phase of Trial: Phase II
Latest Information Update: 03 Dec 2018
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At a glance
- Drugs Dexamethasone (Primary)
- Indications Ocular inflammation; Ocular pain
- Focus Registrational; Therapeutic Use
- Sponsors Ocular Therapeutix
- 03 Dec 2018 According to an Ocular Therapeutix media release, based on the data of two phase 3 studies and a phase 2 study, the US FDA has approved the DEXTENZA (dexamethasone ophthalmic insert) 0.4mg for intracanalicular use for the treatment of ocular pain following ophthalmic surgery.
- 08 May 2018 According to an Ocular Therapeutix media release, the company expects to resubmit the Dextenza NDA in the second quarter of 2018.
- 11 Jul 2017 According to an Ocular Therapeutix media release, the company has received CRL from the U.S. FDA, regarding its resubmission of a NDA for dexamethasone insert 0.4mg for the treatment of ocular pain following ophthalmic surgery. It states, the FDA cannot approve the NDA in its present form due to the deficiencies in manufacturing processes and analytical testing related to manufacture of drug product for commercial production identified during a pre-NDA approval inspection in May 2017.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History