A Phase III, Double-Masked, Randomized, Controlled Trial of KPI-121 in Postsurgical Inflammation
Latest Information Update: 01 Sep 2023
At a glance
- Drugs Loteprednol etabonate (Primary)
- Indications Ocular inflammation; Ocular pain; Postoperative inflammation; Postoperative pain
- Focus Registrational; Therapeutic Use
- Acronyms Hawaii-1
- Sponsors KALA BIO; Kala Pharmaceuticals
- 02 Aug 2023 According to a Kala Pharamceuticals media release, Kala Pharamceuticals has changed its name to KALA BIO.
- 23 Aug 2018 The U.S. Food and Drug Administration (FDA) has approved INVELTYSTM (loteprednol etabonate ophthalmic suspension) 1% for the treatment of post-operative inflammation and pain following ocular surgery, according to a Kala Pharmaceuticals media release.
- 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.