Trial Profile
A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 3 Study Evaluating the Efficacy and Safety of OTX-DP for the Treatment of Chronic Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (CAC)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 02 Nov 2021
Price :
$35
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At a glance
- Drugs Dexamethasone (Primary)
- Indications Allergic conjunctivitis
- Focus Registrational; Therapeutic Use
- Sponsors Ocular Therapeutix
Most Recent Events
- 28 Oct 2021 According to an Ocular Therapeutix media release, A pooled analysis of randomized, controlled clinical trials assessing efficacy (three Phase 3 clinical trials) will be presented at the American Academy of Ophthalmology (AAO) 2021.
- 11 Oct 2021 According to an Ocular Therapeutix media release, the U.S. Food and Drug Administration (FDA) has approved its Supplemental New Drug Application (sNDA) to broaden the DEXTENZA label to add an additional indication for the treatment of ocular itching associated with allergic conjunctivitis.
- 04 Mar 2021 According to an Ocular Therapeutix media release, the supplemental New Drug Application (sNDA) for DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg for intracanalicular use has been accepted for review by the U.S. Food and Drug Administration (FDA). The FDA has set an action date under the Prescription Drug User Fee Act (PDUFA) of no later than October 18, 2021.