Kala plans advancement of dry eye treatment
Kala Pharmaceuticals plans to submit a new drug application to the FDA this year for a formulation of a short-term treatment for dry eye disease, according to a company press release.
KPI-121 0.25% is being investigated as a 2-week course of therapy intended for the temporary relief of the signs and symptoms of dry eye. The formulation uses “Kala’s mucus-penetrating particle (MPP) technology to enhance penetration of loteprednol etabonate (LE) into target tissue of the eye,” the release said.
Data from one phase 2 trial and two phase 3 efficacy and safety trials will be included in the NDA, and the company plans to begin another phase 3 evaluation trial based on recommendations from the FDA, the release said. Results from the additional phase 3 clinical trial, called STRIDE 3, are expected in 2019.
An NDA for MPP-facilitated delivery of corticosteroid (KPI-121 1%) is currently under consideration by the FDA for treatment of inflammation and pain following ocular surgery, with a PDUFA date of August 24.