Additional Relevant Details
The new drug application for lifitegrast now includes data from five clinical trials, including one Phase 2 study, three Phase 3 safety and efficacy studies (OPUS-1, OPUS-2 and OPUS-3) and one long-term (one year) Phase 3 safety study (SONATA). This is the largest clinical trial program for an investigational-stage compound in dry eye disease with over 2,500 patients.
Shire originally submitted the NDA for lifitegrast to the FDA in February 2015. In April 2015, the FDA granted Priority Review designation to lifitegrast, which accelerated the review target to eight months instead of the standard 12 months.