Posted by Michael Wonder on 06 Jan 2018
Kala Pharmaceuticals announces new drug application for Inveltys (KPI-121 1%) has been accepted for review by the U.S. FDA
5 January 2018 - PDUFA target action date of 24 August 2018.
Kala Pharmaceuticals today announced that the new drug application for Inveltys (KPI-121 1%), a topical twice-a-day product candidate for the treatment of inflammation and pain in patients who have undergone ocular surgery, has been accepted for review by the United States FDA. The FDA, in its 74-day letter, indicates that the application is sufficiently complete to permit a substantive review and has set a target action date under the Prescription Drug User Fee Act of 24 August 2018. If approved, Inveltys is expected to be the first twice-daily ocular corticosteroid indicated for the treatment of post-operative ocular inflammation and pain. The brand name for KPI-121 1%, Inveltys, has been conditionally approved by the FDA.
The NDA submission for Inveltys was supported by positive data from two Phase 3 clinical trials, in each of which Inveltys administered twice-a-day to patients following cataract surgery achieved statistical significance for both primary efficacy endpoints of complete resolution of inflammation at day 8 maintained through day 15 with no need for rescue medication compared to placebo and complete resolution of pain at day 8 maintained through day 15 with no need for rescue medications compared to placebo. Inveltys was found to be well tolerated with no treatment-related serious adverse events observed during the course of either trial.
