US FDA accepts NDA for KPI-121 for dry eye

The New Drug Application (NDA) for KPI-121 0.25%, a product candidate for the temporary relief of signs and symptoms of dry eye disease utilizing a two-week course of therapy, has been accepted for review by the United States Food and Drug Administration, said the drug’s developer, Kala Pharmaceuticals (Nasdaq: KALA). Whose shares initially dropped 2.15% to $4.50 following the announcement yesterday, though closed the day unchanged.

The FDA has set a target action date under the Prescription Drug User Fee Act (PDUFA) of August 15, 2019. If approved, KPI-121 0.25% is expected to be the first product indicated for the temporary relief of the signs and symptoms of dry eye disease, which would include treatment of dry eye flares.

“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,” said Dr Edward Holland, director of Cornea Services, Cincinnati Eye Institute and Professor of Clinical Ophthalmology, University of Cincinnati, adding: “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.”