Shire will be resubmitting its application to the FDA early next year on the strength of these improved results.
Shire's OPUS-3 Phase 3 Trial with Lifitegrast Meets Primary and Key Secondary Endpoints, Significantly Reducing Patient-Reported Symptoms for Dry Eye Disease
...."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," said , Ph.D., Head of Research & Development, 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."