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FDA accepts Kala’s NDA for dry eye treatment
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The FDA has accepted a new drug application for Kala Pharmaceuticals’ KPI-121 0.25% for the temporary relief of dry eye signs and symptoms, the company announced in a press release.
The drug uses Kala’s AMPPLIFY mucus-penetrating particle drug delivery technology to target delivery of loteprednol etabonate to ocular tissues and is intended as a 2-week course of therapy, according to the release.
Kala’s NDA submission was supported by a phase 2 clinical trial and two phase 3 STRIDE trials.
“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,” Edward Holland, MD, director of cornea services at Cincinnati Eye Institute, said in the release. “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.”
The FDA has set a PDUFA target action date for the drug for Aug. 15, 2019.