A Phase 3, Double-Masked, Randomized, Controlled Study to Evaluate the Safety and Efficacy of KPI-121 1.0% Ophthalmic Suspension in Subjects With Postsurgical Inflammation and Pain
Phase of Trial: Phase III
Latest Information Update: 29 Jan 2018
At a glance
- Drugs Loteprednol etabonate (Primary)
- Indications Inflammation; Pain
- Focus Registrational; Therapeutic Use
- Sponsors Kala Pharmaceuticals
- 05 Jan 2018 According to a Kala Pharmaceuticals media release, the US FDA has accepted New Drug Application (NDA) for INVELTYSTM (KPI-121 1%),for the treatment of inflammation and pain in patients who have undergone ocular surgery, for review and has set a target action date under the Prescription Drug User Fee Act (PDUFA) of August 24, 2018.
- 25 Oct 2017 According to a Kala Pharmaceuticals media release, based on the data from this and another phase III trial, the company has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for INVELTYSTM (KPI-121 1%), a topical twice-a-day product candidate for the treatment of inflammation and pain in patients who have undergone ocular surgery.
- 15 Aug 2017 Status changed from active, no longer recruiting to completed.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History