With positive key trial, Kala Pharma's dry eye drug Eysuvis emulates approval path set by Xiidra
Mixed data from previous study readouts on its drug for short-term dry eye relief precipitated a rejection from the FDA, leaving Kala Pharmaceuticals’ fate in the hands of a third study. On Monday, that trial met its goals, setting up the Watertown, Massachusetts-based company to resubmit a marketing application in the second quarter.
The drug, to be branded as Eysuvis, consistently met the main efficacy goals — but not the symptom endpoints — across one mid-stage and two late-stage (STRIDE-1 and 2) trials. The company, one of the plethora of biotechs that trace their roots to the prolific lab at MIT led by Bob Langer, was spurned by the FDA last August. While disappointing, the CRL was not completely unexpected, COO Todd Bazemore said at the time.
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