Kala Pharmaceuticals announced that the new drug application (NDA) 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 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 (PDUFA) of August 24, 2018. If approved, Inveltys is expected to be the first twice-daily ocular corticosteroid indicated for the treatment of postoperative ocular inflammation and pain. The brand name for KPI-121 1%, Inveltys, has been conditionally approved by the FDA.
“All currently marketed steroids for the treatment of postsurgical inflammation and pain are approved with four-times-a-day dosing,” Terry Kim, MD, Professor of Ophthalmology and Chief of the Cornea and External Disease Service in the Department of Ophthalmology at Duke University Eye Center, said in a company news release. “This regimen can be significantly burdensome for patients. Based on its efficacy and safety results, as well as its unique twice-daily dosing, I believe that if approved, Inveltys will be an important new treatment option for patients and physicians alike.”
Inveltys utilizes Kala’s proprietary Mucus Penetrating Particle (MPP) technology. MPPs are selectively-sized nanoparticles with proprietary coatings that Kala believes significantly enhance drug penetration and distribution in ocular tissues. In preclinical studies, MPPs increased delivery into ocular tissues more than three-fold by facilitating penetration through the tear film mucus.
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.
“The FDA’s acceptance of the NDA filing for Inveltys is another significant milestone for the company towards our mission of developing innovative treatments for ocular conditions using our MPP technology,” Kim Brazzell, PhD, Chief Medical Officer of Kala Pharmaceuticals, said in the news release.