OCT 27, 2015
Comprehensive Ophthalmology, Cornea/External Disease
Shire Plc. today announced that lifitegrast met its primary and secondary endpoints, demonstrating significant improvement in patient-reported dry-eye symptoms.
Earlier this month, the FDA requested an additional clinical trial and further information after previous trials showed mixed results. Top-line results from this newest phase 3 study (OPUS-3) shows lifitegrast met its primary goal of significantly improving patient-reported symptoms compared to placebo at 12 weeks (p<0.0007). Additionally, the novel cytokine-inhibiting drug met its secondary goal of improving symptoms at weeks 2 and 6 (P<0.0001 for both time points).
Shire expects these results will satisfy the FDA’s request for an additional clinical study, and plans to resubmit its new drug application in the first quarter of 2016. The company expects a U.S. launch next year.
Principle investigator Edward Holland, MD, said, “With OPUS-3, Shire has done something that has never been done before in a phase 3 clinical program in terms of demonstrating replicative symptom improvement. The symptom improvement seen as early as 2 weeks also is impressive. OPUS-3 was an extremely well-run, highly powered clinical trial and the patient enrollment size for the entire lifitegrast clinical program has been rarely seen for ocular surface conditions. I’m excited about these positive data for lifitegrast and the potential for a new treatment option for patients for dry eye disease.”