Shire announced that Xiidra (lifitegrast ophthalmic solution) 5%, a twice-daily prescription eye drop indicated for the treatment of both the signs and symptoms of dry eye disease, is now available by prescription in the United States. An estimated 16 million adults in the U.S. are diagnosed with dry eye, a disease associated with inflammation that may eventually lead to damage to the surface of the eye. 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. The U.S. Food and Drug Administration (FDA) approved Xiidra on July 11, 2016.
“Shire worked rapidly to bring Xiidra to market following the approval of this new treatment – a first-in-its-class medication and the first prescription treatment to be approved for both the signs and symptoms of dry eye disease,” said Perry Sternberg, Head, U.S. Commercial. “We have a full range of modern, educational access programs to support the millions of patients across the U.S. living with dry eye disease. This delivers on our commitment to showing up differently in ophthalmics.”
“As the number of people presenting with the signs and symptoms of dry eye disease increases, the availability of a new prescription treatment option for this condition is an exciting development,” Eric D. Donnenfeld, M.D., FAAO, National Medical Director, TLC Laser Eye Centers. “We now have a new prescription eye drop that is specifically indicated for the signs and symptoms of dry eye disease, an often common eye condition that may be progressive.”
With the availability of Xiidra, Shire has patient-focused resources to share information about prescription coverage and savings (subject to eligibility):
- ask iiris, a phone service offering live-person responses to questions regarding information about insurance coverage, benefits, co-pays and availability in pharmacies. To ask iiris, please call 1-844-my-iiris.
- Xiidra iinsider, an optional program that patients can sign up for to receive information and special offers, either via text or email.
About Xiidra (lifitegrast ophthalmic solution) 5%
Xiidra™ (lifitegrast ophthalmic solution) 5% is a prescription eye drop indicated for the treatment of signs and symptoms of dry eye disease. It is dosed twice per day, approximately 12 hours apart, in each eye. The active ingredient in Xiidra, lifitegrast, binds to the integrin lymphocyte function-associated antigen-1 (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). ICAM-1 may be overexpressed in corneal and conjunctival tissues in patients with dry eye disease. This interaction can contribute to the formation of an immunological synapse resulting in T-cell activation and migration to target tissues. In vitro studies demonstrated that lifitegrast may inhibit T-cell adhesion to ICAM-1 in a human T-cell line and may inhibit secretion of inflammatory cytokines in human peripheral blood mononuclear cells. The exact mechanism of action of lifitegrast in dry eye disease is not known. Xiidra is packaged in a foil pouch containing five low density polyethylene 0.2 mL single-use containers, and is supplied in a carton of 60 single use containers.
Filed Under: Drug Discovery
