Kala is focused on developing innovative nanoparticle-based treatments for ocular diseases affecting both front and back of the eye. Kala leverages its proprietary mucus-penetrating particle (MPP) technology to enhance topical delivery into ocular tissues.
Our proprietary nanoparticle-based Mucus Penetrating Particles, or MPPs, are selectively-sized nanoparticles and have proprietary coatings. We believe that these two key attributes enable even distribution of drug particles on mucosal surfaces and significantly increase drug delivery to target tissues by enhancing mobility of drug particles through mucus and preventing drug particles from becoming trapped and eliminated by mucus.
We have applied the MPP technology to create nanosuspensions of loteprednol etabonate, or LE, a corticosteroid designed for ocular applications, resulting in two product candidates in Phase 3 clinical development:
- KPI-121 1.0% for the treatment of inflammation and pain following ocular surgery: KPI-121 1.0% is our topical twice-a-day product candidate for patients with inflammation and pain following cataract surgery, which is the most common type of ocular surgery in the United States. Commonly used topical ocular corticosteroid products for the treatment of post-operative inflammation and pain are approved for dosing four times a day. We have completed two Phase 3 clinical trials of KPI-121 1% for the treatment of inflammation and pain following cataract surgery. In May 2017, we announced topline results from the second, confirmatory Phase 3 clinical trial. In this second Phase 3 clinical trial, administration of KPI-121 1.0% two times a day achieved statistical significance for both primary efficacy endpoints of complete resolution of inflammation at day eight maintained through day 15 with no need for rescue medication compared to placebo and complete resolution of pain at day eight maintained through day 15 with no need for rescue medications compared to placebo and all secondary endpoints. KPI-121 1.0% was well tolerated with no treatment-related significant adverse events observed during the course of the trial. Based on the results of our two successfully completed Phase 3 trials of KPI-121 1.0%, we anticipate submitting an NDA for the approval of KPI-121 1.0% for the treatment of post-operative inflammation and pain following ocular surgery by the end of 2017. If approved, KPI-121 1.0% could be the first FDA-approved ocular corticosteroid product for the treatment of post-operative inflammation and pain with twice daily dosing.
- KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease: KPI-121 0.25% is our product candidate for patients with dry eye disease utilizing a two-week course of therapy. After achieving positive results in a Phase 2 clinical trial, we initiated two parallel Phase 3 clinical trials of KPI-121 0.25% in June 2016. We expect to receive topline results from these clinical trials by the end of 2017. Assuming positive results from these Phase 3 clinical trials, we anticipate submitting an NDA for KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease in the first half of 2018. If approved, KPI-121 0.25% could be the first FDA-approved product for the short-term treatment of dry eye disease.