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:
- INVELTYS™ (KPI-121 1.0%) for the treatment of inflammation and pain following ocular surgery. INVELTYS 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 INVELTYS 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 INVELTYS 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. INVELTYS was well tolerated with no treatment-related significant adverse events observed during the course of the trial. Based on these results, a New Drug Application (NDA) was filed with the FDA in October of 2017 and in December of 2017 the NDA was accepted with a target action date under the Prescription Drug User Fee Act (PDUFA) of August 24, 2018. If approved, INVELTYS 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. In January 2018, we announced topline results from two completed Phase 3 clinical trials, which we refer to as STRIDE 1 and STRIDE 2 (STRIDE – Short Term Relief In Dry Eye), evaluating the safety and efficacy of KPI-121 0.25% versus placebo in patients with dry eye disease. In the STRIDE 1 trial, statistical significance was achieved for the primary sign endpoint of conjunctival hyperemia and the primary symptom endpoint of ocular discomfort severity change from baseline to day 15 in the intent to treat, or ITT, population. In the STRIDE 2 trial, statistical significance was achieved for the primary sign endpoint of conjunctival hyperemia, but statistical significance was not achieved for the primary symptom endpoint of ocular discomfort severity. KPI-121 0.25% was generally well tolerated in both STRIDE 1 and STRIDE 2, with no clinically significant treatment-related adverse events observed during the course of either trial, and with elevations in IOP in both trials similar to placebo. If approved, KPI-121 0.25% could be the first FDA-approved product for the short-term treatment of dry eye disease.