FDA accepts Kala’s NDA for dry eye treatment

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

Full Story →