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

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 significance for symptom relief of ocular discomfort severity (ODS) from baseline in both the overall intent-to-treat STRIDE 3 population, as well as in a predefined subgroup with more severe ODS at baseline