10.16.18
Kala Pharmaceuticals Submits NDA to FDA for KPI-121 0.25% for Dry Eye Disease
Source: Kala Pharmaceuticals
Kala Pharmaceuticals announced that it has submitted a new drug application (NDA) to the FDA for KPI-121 0.25%, a topical product candidate which, if approved, could be the first FDA-approved product for the temporary relief of signs and symptoms of dry eye disease.
There are an estimated 33 million patients with dry eye disease in the United States and Kala’s market research indicates that approximately 90% of these patients have flares associated with their dry eye disease. If approved, KPI-121 0.25% could offer a favorable management option for these dry eye flares and other dry eye-associated conditions.
KPI-121 0.25% utilizes Kala’s AMPPLIFY mucus-penetrating particle (MPP) drug delivery technology, which are selectively-sized nanoparticles with proprietary coatin
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