Shire's Dry Eye Drug Submitted to FDA for Approval

Shire plc has submitted a New Drug Application to the FDA for its investigational compound designed to treat patients with dry eye disease.

“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 research and development at Shire, in a press release.

Lifitegrast works by binding to the integrin lymphocyte function-associated antigen-1, blocking the cell surface protein’s interaction with its ligand, intercellular adhesion molecule-1, which is excessive in the corneal and conjunctival tissues of dry eye patients.

The progressive ocular disease is 1 of the most common complaints to eye care professionals, thus representing a significant unmet medical need, Shire said.

Shire’s submission for lifitegrast’s approval is supported by data from more than 1800 participants in 4 clinical trials on the safety and efficacy of lifitegrast. These trials include a single phase 2 study, a pair of phase 3 efficacy and safety studies, and another long-term phase 3 safety study.