With across-the-board positive data from the 901-patient Phase III STRIDE 3 trial, Kala Pharmaceuticals Inc. believes it is set to re-file KRI-121 for approval in dry eye disease at the US Food and Drug Administration before mid-year. With a provisional brand name of Eysuvis, Kala plans to position its product for short-term treatment of dry eye flare-ups, differentiating it from the established, chronic therapy approaches of Allergan PLC’s Restasis and Novartis AG’s Xiidra.
Kala’s Third Phase III Trial Should Line Up Approval In Dry Eye
Data showing that endpoints were met for both signs and symptoms of dry eye disease should position Kala’s KRI-121 for US approval. The company hopes to differentiate with short-term flare treatment.
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