Shire Launches Xiidra, A Dry Eye New Drug In The United States, Restasis Overlord
British pharmaceutical company Shire recently announced the release of its ophthalmic drug Xiidra (lifitegrast eye drops) to the U.S. market, which was approved by the U.S. Food and Drug Administration (FDA) on July 11 this year for dry eye disease (DED) symptoms and Signs of treatment, which is the first drug approved by the FDA to treat dry eye disease, a lymphoproliferative antigen-1 (LFA-1) antagonist, and the only prescription eye drop in the U.S. market that is used twice daily , Each separated by about 12 hours.
Xiidra is the first new drug in the field of dry eye treatment in the past 13 years. The industry is very optimistic about its business prospects. It is estimated that annual sales will exceed 1 billion U.S. dollars and will become Restasis (Brand Name: , Common name: cyclosporine, cyclosporin).
Currently, Restasis's drug label describes it as increasing the ability of the eye to produce tear fluid, which is actually being targeted as a replacement for artificial tears. The Xiidra label for the treatment of dry eye symptoms and signs, a wider range of labels. In addition, although the two drugs are not head-to-head, clinical data show that Xiidra works faster and can resolve in about two weeks, whereas Restasis takes six weeks or longer. And in terms of price, Xiidra prices and Restasis consistent, about 5000 US dollars / year, it is foreseeable that the dry eye treatment market will be explosive confrontation.
According to Elke, Restasis, which had sales of about $ 1.3 billion last year, is the second-largest product after the company's wrinkle-free product, Botox. Some analysts believe that although Xiidra will pose a serious threat to Restasis, the increased awareness of dry eye treatment associated with the intense confrontation of two products on the market will actually benefit Restasis as well.
For the past three years, Shire has established an ophthalmic franchise through a series of acquisitions, while Xiidra acquired the company with a 160 million acquisition of SARcode Bioscience in 2013.
It is worth mentioning that in the European market, the dry eye medicine Ikervis (ciclosporin) developed by Japan's Santen Pharma was approved by the European Union in March last year for treatment of artificial tears for improved dryness Serious keratitis in adult patients with eye diseases became the first prescription for dry eye in Europe.
About Xiidra (lifitegrast) and Dry Eye Disease
lifitegrast is a novel small molecule integrin inhibitor that binds to the integrin LFA-1 (lymphocyte function associated antigen-1) and blocks LFA-1 from its cognate ligand ICAM-1 (intercellular adhesion molecule- 1) interactions. LFA-1 is a protein present on the surface of leukocytes. In dry eye, ICAM-1 is overexpressed in corneal and conjunctival tissues. The LFA-1 / ICAM-1 interaction promotes the formation of immune synapses, resulting in T cell activation and migration to the target tissue.
Dry eye disease (DED), also known as keratoconjunctivitis sicca (KCS), refers to any cause of abnormal or abnormal tear fluid quality or kinetics, resulting in decreased tear film stability, accompanied by eye discomfort and ( Or) ocular surface lesions of various diseases characterized by a general term. It is currently the most common ocular surface disease, the main treatment is the use of artificial tears.