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: 11 Jul 2017
At a glance
- Drugs Dexamethasone (Primary)
- Indications Ocular inflammation; Ocular pain
- Focus Therapeutic Use
- Sponsors Ocular Therapeutix
- 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.
- 11 May 2017 According to an Ocular Therapeutix media release, the upcoming PDUFA (Prescription Drug User Fee Act (PDUFA)) date 19 Jul 2017, set by the the U.S. Food and Drug Administration (FDA) is for a New Drug Application (NDA) for the treatment of ocular pain following ophthalmic surgery based on a phase 2 trial (NCT01666210) and two phase 3 trials (NCT02089113 and NCT02034019) independent of the third and most recent phase 3 study results.
- 25 Jul 2016 According to Ocular Therapeutix media release, company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for DEXTENZA (dexamethasone insert) 0.4 mg, for intracanalicular use in the treatment of ocular pain occurring after ophthalmic surgery.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History