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 (Read more...)
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