The New Drug Application (NDA) for Inveltys (KPI-121 1%; Kala) has been accepted by the Food and Drug Administration (FDA), with a target action date set for August 24, 2018.
Inveltys is an investigational topical twice-a-day product candidate for the treatment of inflammation and pain in patients who have undergone ocular surgery. The NDA is supported by 2 Phase 3 trials in which Inveltys was administered to patients following cataract surgery. Both trials met their primary endpoints of complete resolution of inflammation and pain at day 8 through day 15, without a need for any rescue medications.
Currently, ocular steroids used for treating post-surgical inflammation and pain are approved for 4-times-a-day dosing; if approved, Inveltys would become the first twice-daily ocular steroid for post-surgical topical treatment.
“I believe that if approved, Inveltys will be an important new treatment option for patients and physicians alike,” said Dr Terry Kim, Chief of the Cornea and External Disease Service in the Department of Ophthalmology at Duke University Eye Center.
The treatment uses Kala’s Mucus Penetrating Particle (MPP) technology, which according to the Company, enhances drug penetration and distribution in ocular tissues. In the trials, Inveltys was found to be well-tolerated with no serious adverse events.
Kala Pharmaceuticals announces New Drug Application for Inveltys™ (KPI-121 1%) has been accepted for review by the US Food and Drug Administration [press release]. Waltham, MA; Business Wire: January 5, 2018. Accessed January 22, 2018.
This article originally appeared on MPR