Kala Pharmaceuticals (NSDQ:KALA) said today that the FDA accepted the new drug application for Kala’s dry eye disease therapy, KPI-121 0.25%.
The two-week treatment features Kala’s mucus-penetrating particle drug-delivery technology and is designed for the temporary relief of sings and symptoms of dry eye disease.
The FDA is slated to make a decision about KPI-121 0.25% by Aug. 15, 2019.
Kala’s NDA application included data from a clinical trial program that included more than 2,000 people with dry eye disease. Based on a recommendation from the FDA, Kala launched another Phase III trial for KPI-121 0.25% in July this year. The company plans to report top-line data from the trial in the fourth quarter of 2019.
“All currently marketed FDA-approved pharmaceutical treatments for dry eye disease are chronic therapies and are typically used in patients with chronic or persistent dry eye symptoms,” Dr. Edward Holland, director of cornea services at the Cincinnati Eye Institute, said in prepared remarks.
“The vast majority of patients experience episodic dry eye flares that are characterized by acute exacerbations of signs and/or symptoms. An FDA-approved, safe and effective short-term treatment for dry eye disease, including dry eye flares, will represent an important new treatment option for patients and prescribers,” Holland added.
