• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • Benchmark Reports
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA accepts Ocular’s NDA resubmission for DEXTENZA

FDA accepts Ocular’s NDA resubmission for DEXTENZA

February 22, 2017
CenterWatch Staff

Ocular Therapeutix, a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, has announced that the company’s New Drug Application (NDA) resubmission for DEXTENZA (dexamethasone insert) 0.4mg for intracanalicular use, for the treatment of ocular pain occurring after ophthalmic surgery has been accepted as a filing for review by the FDA. DEXTENZA is a product candidate administered by a physician as a bioresorbable intracanalicular insert and designed for drug release to the ocular surface for up to 30 days.

The FDA determined that the NDA resubmission is a complete response and designated the resubmission as a Class 2 review, with a target action date under the Prescription Drug User Fee Act (PDUFA) of July 19, 2017, for the potential approval of DEXTENZA.

“We are pleased the FDA has accepted our resubmission of the DEXTENZA NDA and that we now have clarity on the PDUFA target action date. We look forward to advancing this process toward our goal of the potential approval and commercial launch of DEXTENZA,” said Amar Sawhney, Ph.D., president, chief executive officer and chairman. “With nearly four million cataract surgeries performed in the U.S. in 2016 as our initial target, the market opportunity for DEXTENZA is significant. If approved, we believe DEXTENZA will be the first non-invasive therapy available to patients and ophthalmologists that can provide a full post-operative course of therapy with a single placement.”

    Upcoming Events

    • 16Oct

      MAGI@home Clinical Research Conference 2023

    • 25Oct

      2023 WCG Patient Forum

    • 26Oct

      FDA in 2024: What to Expect in an Election Year

    Featured Products

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    • Best Practices for Clinical Trial Site Management

      Best Practices for Clinical Trial Site Management

    Featured Stories

    • Donna Snyder

      New WCG Executive Physician Outlines Goals for Clinical Research

    • Hand Shake at Meeting

      Partnership to Bolster Trials in Low Resource Regions Kicks Off

    • Guidelines-360x240.png

      Major Industry Groups Offer Feedback on ICH’s E6(R3) Guidelines

    • AsktheExpertsBadge-360x240.png

      Ask the Experts: Monitoring

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing