Kala Pharmaceuticals has submitted a New Drug Application (NDA) for KPI-121 0.25%, a topical product candidate for the temporary relief of the signs and symptoms of dry eye disease. The product was developed using Kala’s AMPPLIFY mucus-penetrating particle drug delivery technology, which in preclinical trials, enhanced the penetration of loteprednol etabonate, a corticosteroid, into the target tissue of the eye.
The NDA includes data from one Phase 2 and two Phase 3 clinical trials (STRIDE 1 and STRIDE 2) involving ~2000 individuals with dry eye disease. Topline results from a third trial, STRIDE 3, are expected in the fourth quarter of 2019.
“We believe the data from STRIDE 1, STRIDE 2 and the Phase 2 trials demonstrate a robust data package supporting the clinically meaningful efficacy, safety and tolerability of KPI-121 0.25%,” said Kim Brazzell, PhD, CMO of Kala Pharmaceuticals.
For more information visit Kalarx.com.