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Kala’s Third Phase III Trial Should Line Up Approval In Dry Eye

 
• By Joseph Haas

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.

Concept of eyesight, closeup of one eye with a target centred
Kala is targeting approval of Eysuvis by year's end in dry eye disease

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.

The Watertown, MA-based firm revealed on 9 March that KR1-121, a 0.25% strength ophthalmic suspension of loteprednol etabonate, demonstrated statistical...

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