The first new drug, KPI-121, which temporarily relieves symptoms and signs of dry eye disease, including flares, is under review in the United States

Kala Pharma is a Massachusetts-based biopharmaceutical company focused on developing and commercializing new drugs for eye diseases using its proprietary nanoparticle-based mucus-penetrating particle (MPP) drug delivery technology. Recently, the company announced that the U.S. Food and Drug Administration (FDA) has accepted a new drug application (NDA) for the dry eye drug KPI-121 (0.25%) for temporary relief of the symptoms and signs of dry eye disease for 2 weeks. The FDA has designated the target date for the NDA Prescription Drug User Charge Act (PDUFA) as August 15, 2019. If approved, KPI-121 (0.25%) is expected to be the first product to temporarily relieve symptoms and signs of dry eye disease, including the treatment of dry eye flares.
"All FDA-approved dry eye medications currently on the market are chronic therapies, typically used in patients with chronic or persistent dry eye symptoms," said Dr. Edward Holland, a professor of ophthalmology at the University of Cincinnati and director of corneal services at the Cincinnati Eye Institute. The vast majority of patients experience intermittent dry eye flares characterized by acute symptoms and/or deterioration of signs. An FDA-approved safe and effective short-term dry eye treatment, including dry eye flares, will provide patients and prescribers with new and important treatment options. The
KPI-121 (0.25%) leverages Kala's proprietary AMPPLIFY drug delivery technology to enhance penetration of eye target tissue. In preclinical studies, AMPPLIFY technology delivered lesions three times more to eye tissue by promoting the penetration of tear membrane mucous proteins than currently on the market for LE-based products.
AMPPLIFY technology has also been used in Kala's other eye product, Inveltys (1%), the first corticosteroid product to be approved by the FDA in August 2018 to treat inflammation and pain after eye surgery. Currently, all other eye steroid drugs on the market are approved only four times a day, and this more frequent dosing requirement can cause problems for doctors and patients.
submission of the KPI-121 (0.25%) NDA is based on data from a Phase II study and two Phase III Efficacy and Safety Studies (STRIDE-1, STRIDE-2). The study included more than 2,000 patients with dry eye disease. In accordance with FDA recommendations, Kala also initiated Phase III Clinical Study STRIDE-3 in July 2018 to evaluate KPI-121 (0.25%) for temporary relief of dry eye signs and symptoms. The company expects to release data for Phase III research in the fourth quarter of 2019.
dry eye disease (DRY eye disease, DED) is a chronic, intermittent, multi-factor disease that affects tear fluid and eye watches and can lead to instability of the tear membrane, inflammation, discomfort, visual impairment, and eyelid damage. Dry eye disease affects an estimated 33 million people in the United States, with an estimated incidence rate of 14.5 per cent. Dry eye disease can have a significant impact on the quality of life of patients and can cause long-term damage to the eyelids. In addition, the vast majority of patients with dry eye disease experience acute exacerbation of symptoms at different times of the year, often referred to as flares. These flares can be triggered by a number of factors that cause inflammation of the eye surface and affect tear production and/or tear membrane stability. Dry eye disease is currently the most common eye disease, the main treatment is the use of artificial tear fluid. (Bio Valley)