A Phase III, Double-Masked, Randomized, Controlled Trial of KPI-121 in Postsurgical Inflammation
Phase of Trial: Phase III
Latest Information Update: 25 Oct 2017
At a glance
- Drugs Loteprednol etabonate (Primary)
- Indications Ocular inflammation; Ocular pain
- Focus Registrational; Therapeutic Use
- Acronyms Hawaii-1
- Sponsors Kala Pharmaceuticals
- 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.
- 01 Apr 2015 Top-line results published in a Kala Pharmaceuticals media release.
- 01 Apr 2015 Primary endpoint 'Resolution of Ocular Pain' at day 8 has been met, according to a Kala Pharmaceuticals media release.