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ARTICLE | Clinical News

Lifitegrast: Phase III data

May 5, 2014 7:00 AM UTC

Top-line data from the double-blind, placebo-controlled, U.S. Phase III SONATA safety trial in 332 patients with dry eye disease showed that twice-daily 5% lifitegrast led to no ocular or treatment-related serious adverse events. Additionally, ocular adverse events in patients receiving lifitegrast compared to placebo at 1 year included installation site irritation (15% vs. 4.5%), installation site reaction (13.2% vs. 1.8%), visual acuity reduction (11.4% vs. 6.3%) and dry eye (1.8% vs. 5.4%). The most common reported non-ocular adverse event associated with lifitegrast was dysgeusia. The trial enrolled patients with a visual analog score of >=40% in either symptom of eye dryness or discomfort, a corneal staining score of >=2 points in at least 1 region in either eye and a Schirmer Tear Test score of >=1 and <=10 mm in either eye. Shire said it plans to meet with FDA to discuss the totality of the Phase III data for lifitegrast and determine a path forward, but could not be reached for details. ...