The FDA will review the NDA for KPI-121 0.25%, which is designed to provide temporary relief to the signs and symptoms of dry eye disease, including dry eye flares.
For the NDA, the prescription drug user fee act (PDUFA) target action date is 15 August 2019.
The NDA is based on results from a Phase ll and two Phase lll trials, STRIDE 1 and STRIDE 2, evaluating the efficacy and safety of KPI-121 0.25% in over 2,000 patients with dry eye disease.
In July this year, Kala commenced an additional Phase lll clinical trial, STRIDE 3, on the basis of recommendation provided by FDA.
The STRIDE 3 trial aims to assess KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease. It expects to provide top-line data in the fourth quarter of next year.
University of Cincinnati Clinical Ophthalmology professor Dr Edward Holland said: “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.
“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.”
KPI-121 0.25% uses a two-week course therapy to treat dry eye disease. It also employs Kala’s Ampplify drug delivery technology to improve penetration into target tissues of the eye.
KPI-121 0.25% is designed to provide temporary relief to the signs and symptoms of dry eye disease.