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.
Shire has announced positive topline results from OPUS-3, a Phase III efficacy and safety study of lifitegrast versus placebo. These data showed OPUS-3 met the primary endpoint of significantly improving patient-reported symptoms of dry eye disease from baseline to day 84 (p=0.0007). In addition, OPUS-3 met the secondary endpoints of symptom improvement from baseline to days 14 and 42 (p<0.0001 for both endpoints). Shire plans to use these data as part of the resubmission of the New Drug Application (NDA) for lifitegrast for the treatment of signs and symptoms for dry eye disease in the first quarter of 2016.
“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.”
Related News
-
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Identifying Alzheimer’s Disease biomarker proteins with whole blood tests
A University of Manchester spin-out pharmaceutical company, PharmaKure, has reported successful study results for the quantification of Alzheimer’s Disease biomarker proteins with a whole blood test. -
News Bill & Melinda Gates Foundation to boost mRNA vaccine initiatives in Africa with USD $40m
To address vaccine inequality and accessibility issues, the Bill & Melinda Gates Foundation aims to deliver USD $40m to various biotech companies and vaccine manufacturers in support of mRNA vaccine development. -
News CPHI Podcast Series: Exploring neurological frontiers in Alzheimer's and beyond
The next episode of the CPHI Podcast Series delves into the science and background behind some recent developments in the field of Alzheimer's disease and neurological disorders. -
News Is patient centricity the future of pharmaceutical manufacturing?
In this interview with Sandra Sánchez y Oldenhage, President of PharmAdvice, she speaks to the importance of considering patients in the manufacturing stages of the pharmaceutical supply chain, and how it can redefine healthcare. -
News CPHI Podcast Series: How to leverage AI for Drug Discovery
Artificial intelligence is the topic of debate in the latest episode from the CPHI Podcast Series, where Digital Editor Lucy Chard speaks with Bill Whitford of DPS Group about the integration of AI in healthcare. -
News Pfizer forges ahead with blood cancer therapy after approval from FDA
Pfizer gains accelerated approval from the US FDA for their new bispecific antibody therapy for multiple myeloma, set to address an unmet need for patients. -
News Alzheimer's drug donanemab deemed effective in landmark clinical trial
Results from the TRAILBLAZER-ALZ 2 Randomised Clinical Trial into the use of donanemab to treat early symptoms of Alzheimer’s disease have been analysed.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance