The US Food and Drug Administration (FDA) has accepted to review the New Drug Application (NDA) for KPI-121 0.25%, an investigational dry eye drug, developed by Kala Pharmaceuticals.
The US biopharma company is seeking the FDA approval for KPI-121 0.25% to be used for providing temporary relief of signs and symptoms of dry eye disease through a two-week course of therapy.
The target action date for the drug’s approval decision by the FDA under the Prescription Drug User Fee Act (PDUFA) is 15 August, 2019.
Kala Pharmaceuticals claims that if approved, KPI-121 0.25% is anticipated to be the first dry eye drug indicated by the regulator for the temporary relief of the signs and symptoms of dry eye disease, which would include dry eye flares treatment.
Dr. Edward Holland, Director of Cornea Services, Cincinnati Eye Institute and Professor of Clinical Ophthalmology, University of Cincinnati, 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’s NDA submission is backed by the findings of a Phase 2 and two Phase 3 efficacy and safety trials, called STRIDE 1 and STRIDE 2, respectively, which have together enrolled more than 2,000 patients with dry eye disease.
Kala Pharmaceuticals has also launched an additional Phase 3 clinical trial, called STRIDE 3, for the dry eye drug, on recommendation of the FDA, in July 2018. The STRIDE 3 trial is assessing KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease. Top-line results for the late-stage trial of the dry eye drug are expected to come out in Q4 2019.
KPI-121 0.25% has been developed using the AMPPLIFY Drug Delivery Technology of Kala Pharmaceuticals to improve penetration into target tissues of the eye.
In preclinical studies, the drug delivery technology was shown to have increased delivery of loteprednol etabonate (LE) into ocular tissues more than three times in comparison to current LE products by enabling penetration through the tear film mucins.