Shire shares rose 6% today as the company reported new positive Phase III trial data for lifitegrast in the treatment of dry eye disease.
Having been rocked by the FDA’s rejection of the drug earlier this month, where the regulator asked for more information, Shire said the new data would fulfil this request and that it intends a resubmission to the Authority in Q1 2016, followed by the launch of lifitegrast in the US in late 2016.
Topline data showed OPUS-3 met its primary endpoint, demonstrating significant improvement in patient-reported symptoms from baseline to day 84 in patients receiving lifitegrast versus placebo.
Key secondary endpoints were also met, showing symptom improvement from baseline to days 14 and 42 versus placebo, with benefit demonstrated as early as two weeks. Additional analyses and data will be presented at major medical meeting in 2016.
“The results from OPUS-3, where lifitegrast demonstrated symptom improvement as early as two 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,” says Philip Vickers, head of Research & Development at 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.”
Shire CEO Flemming Ornskov, says: “We’re delighted with the positive topline findings from OPUS-3 and look forward to resubmitting to FDA the New Drug Application 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.”
The OPUS-3 results cap a good few days for the Ireland-based company, which reported strong financial results for Q3 on Friday, including 7% growth in product sales.