Shire files for US approval of Lifitegrast for dry eye disease

Ireland-based drugmaker Shire (LSE: SHP) has submitted a New Drug Application with the US Food and Drug Administration for its investigational compound Lifitegrast for the treatment of signs and symptoms of dry eye disease in adults.

“Lifitegrast has potential to be the first treatment indicated to address both the signs and symptoms of dry eye disease, a chronic inflammatory condition which affects millions of people,” said Philip Vickers, head of R&D at Shire, adding: “Our FDA submission is an important milestone that underscores Shire’s commitment to developing innovative specialty medicines in areas of high unmet medical need.”

The NDA submission is supported by the totality of evidence from four clinical trials with more than 1,800 patients. These included one Phase II study, two Phase III efficacy and safety studies, and one long-term Phase III safety study.