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Kala submits NDA for topical dry eye treatment KPI-121 0.25%

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A new drug application has been submitted to the FDA for KPI-121 0.25%, a topical product candidate for dry eye disease, Kala Pharmaceuticals announced in a press release.

KPI-121 0.25%, which utilizes Kala’s Amplify mucus-penetrating drug delivery technology, could be the first FDA-approved product for temporary relief of dry eye signs and symptoms.

The NDA is supported by one phase 2 trial and two phase 3 trials, STRIDE 1 and STRIDE 2, in which KPI-121 0.25% showed statistical significance for the primary endpoint of conjunctival hyperemia, as well as the primary symptom endpoint of ocular discomfort severity.

“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%,” Kim Brazzell, PhD, Kala’s chief medical officer, said in the release. “Today, there are limited treatment options for dry eye disease, and KPI-121 0.25% has the opportunity to address significant unmet needs for patients and health care professionals.”