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.
- 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.