June 21, 2018
1 min read

Kala plans advancement of dry eye treatment

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

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.