Shire announced that the Marketing Authorization Application (MAA) for lifitegrast, submitted on August 7 has been validated. If approved, lifitegrast would be the first and only treatment in a new class of drugs (LFA-1 antagonist) to address the signs and symptoms of dry eye disease in adults in Europe. The disease is most commonly associated with eye dryness and overall eye discomfort, as well as stinging, burning, and fluctuating blurry vision. Dry eye disease may significantly affect quality of life and may impact activities such as reading and using computers. It is one of the most common conditions seen by ophthalmologists and eye care practitioners worldwide.
“This submission is another important milestone for lifitegrast and the millions of patients living with dry eye disease, which can impact a person`s vision-related quality of life, affecting daily activities such as reading and using computers,” said Howard Mayer, M.D., Head of Clinical Development, R&D. “Shire is committed to continued innovation in ophthalmics, where there are opportunities to address unmet need and improve the lives of patients.”
Shire`s MAA for lifitegrast is supported by the largest development program to date for an investigational-stage dry eye disease candidate, consisting of five clinical trials with more than 2,500 patients. In these studies, the signs of dry eye disease were measured using corneal staining and the symptoms by using patient reported eye dryness score (EDS).
About Dry Eye Disease
The prevalence of dry eye disease, with and without symptoms, ranges from 5 to 50% in adults globally. An eye care professional can diagnose dry eye disease based on signs and symptoms and determine management options, which could include the use of a prescription treatment. Dry eye disease is a multifactorial disease of the ocular surface that is often chronic and may be progressive. The disease is most commonly associated with eye dryness and overall eye discomfort, as well as stinging, burning, or fluctuating blurry vision. Dry eye disease may significantly affect quality of life and may impact activities such as reading and using computers.
Ophthalmologists and eye care professionals can diagnose dry eye disease based on patient reported symptoms as well as signs which can be objectively evaluated through various tests.
Management options may include the use of non-prescription and prescription treatments.
Aging and gender are recognized as traditional risk factors of chronic dry eye disease, while modern risk factors include prolonged digital/computer screen time, contact lens wear and cataract or refractive surgery. Dry eye is a common complaint to ophthalmologists and eye care professionals.
About Lifitegrast
Lifitegrast is a lymphocyte function-associated antigen-1 (LFA-1) antagonist, the first medication in a new class of drugs. Lifitegrast binds to the integrin LFA-1, a cell surface protein found on leukocytes and blocks the interaction of LFA-1 with its cognate ligand intercellular adhesion molecule-1 (ICAM-1), which plays a prominent role in ocular surface inflammation. ICAM-1 may be over-expressed in corneal and conjunctival tissues in dry eye disease. LFA-1/ICAM-1 interaction can contribute to formation of an immunological synapse resulting in T-cell activation and migration to target tissues. In vitro studies have shown that lifitegrast may inhibit the recruitment of previously activated T cells, the activation of newly recruited T cells, and the release of pro-inflammatory cytokines-interrupting the perpetual cycle of inflammation.
