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Kala Hopes To Stride Into Dry Eye Market This Year

 
• By Jo Shorthouse

Kala Pharmaceuticals is hoping to shake up the dry eye market with a NDA filing this year for its steroid eye drop KPI-121 0.25%.

Vision
KPI-121 0.25% uses mucus-penetrating particle technology

Kala Pharmaceuticals Inc. is planning to file a new drug application in the US for what it hopes will become the first FDA-approved treatment for short-term dry eye disease, specifically dry eye flares. The $1.7bn dry eye market is currently dominated by Shire PLC and Allergan PLC, with Xiidra (lifitegrast) and Restasis (cyclosporine ophthalmic emulsion) respectively.

While the New Drug Application (NDA) for KPI-121 0.25% (loteprednol etabonate) will be based on existing clinical studies, STRIDE 1 and STRIDE 2, based on the recommendation of the FDA, Kala will run an additional Phase III study, STRIDE 3, in the third quarter of 2018. Top-line results for STRIDE 3 are anticipated in the fourth quarter of 2019

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