Dextenza

NDA 208742, held by Ocular Therapeutix. Dexamethasone.

As of Nov 13, 2026, NDA 208742 (Dextenza), held by Ocular Therapeutix, was first approved by FDA on Nov 30, 2018, with 4 approved supplements and 2 published complete response letters.

First approved: Nov 30, 2018
Review: Standard
Supplements approved: 4
Complete response letters: 2

What It's For

From the FDA-approved label (Indications and Usage)

DEXTENZA is a corticosteroid indicated for: The treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients.. The treatment of ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged 2 years and older. The use of DEXTENZA is not recommended for the treatment of ocular itching associated with allergic conjunctivitis in pediatric patients who require sedation for the insertion procedure.. 1.1 Ocular Inflammation and Pain Following Ophthalmic Surgery DEXTENZA is indicated for the treatment of ocular inflammation and pain following ophthalmic surgery. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below


Apr 7, 2025	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 7, 2021	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 20, 2019	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 30, 2018	Original applicationNew dosage form · Standard review	Approved	Review Letter

Complete Response Letters

FDA's published letters for this application; each opens the letter


Jul 10, 2017	DEXTENZA (dexamethasone ophthalmic insert)Product Quality/Facilities Inspection	Approved
Jul 21, 2016	Dexamethasone insertFacilities Inspection	Approved

Products

1 strengths and forms

Product	Active ingredient	Marketing
Dextenza0.4MG · insert;ophthalmic	Dexamethasone	RxReference drug

All 5 submissions, including labeling and manufacturing supplements


Apr 7, 2025	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 7, 2021	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Label Letter
Mar 2, 2020	Supplement 5Labeling · Standard review	Approved	Letter
Jun 20, 2019	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 30, 2018	Original applicationNew dosage form · Standard review	Approved	Review Letter

Identifiers

Application: NDA 208742
Drugs@FDA: Overview at FDA
Company: Ocular Therapeutix, Inc.

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters