Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase 3B Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery

Trial Profile

A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase 3B Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Sep 2019

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Dexamethasone (Primary)
  • Indications Ocular inflammation; Ocular pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Ocular Therapeutix
  • Most Recent Events

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top