Shire's OPUS-3 Phase II trial with lifitegrast meets primary and key secondary endpoints, significantly reducing patient-reported symptoms for dry eye disease

Data to support lifitegrast FDA resubmission in Q1 2016; plans on track for potential 2016 launch.

“The results from OPUS-3, where lifitegrast demonstrated symptom improvement as early as 2 weeks, provide compelling efficacy data that contribute to the totality of evidence from the lifitegrast clinical development program, now the largest for an investigational stage compound in dry eye disease with more than 2,500 patients,” said Philip J. Vickers, Head of R&D, Shire. “We believe the data from OPUS-3 will satisfy the FDA’s request for an additional clinical study. We welcome the opportunity to share these positive data with the regulatory authorities.”

Flemming Ornskov, CEO, Shire said: “We’re delighted with the positive topline findings from OPUS-3 and look forward to resubmitting to FDA the NDA for lifitegrast for the treatment of signs and symptoms for dry eye disease in the first quarter of 2016. If approved by the FDA, this keeps us on track for a potential US launch next year. We also are planning to use these data, in conjunction with the existing comprehensive clinical data set, for regulatory filings for lifitegrast in other markets outside of the US. We entered the ophthalmics space because we saw tremendous opportunity to address unmet needs in eye care. With these highly statistically significant results, we’re increasingly confident about the potential of lifitegrast and the overall progress we’re making in growing Shire’s presence in ophthalmics.”

“Symptoms of dry eye disease are an enormously common problem – it’s the No. 1 reason patients visit my office,” said Edward Holland, OPUS-3 Principal Investigator and Professor of Ophthalmology, University of Cincinnati and Director, Cornea Service, Cincinnati Eye Institute. “With OPUS-3, Shire has done something that has never been done before in a Phase III clinical program in terms of demonstrating replicative symptom improvement. The symptom improvement seen as early as two 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.”