XiidraTreatment for Dry Eye Disease
Update: Xiidra (lifitegrast) Now FDA Approved - July 11, 2016
Shire Submits NDA to the FDA for Approval of Lifitegrast For Treatment of Dry Eye Disease in Adults
Lexington, Mass. – March 2, 2015 – Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that the company has submitted a New Drug Application (NDA) with the U. S. 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 J. Vickers, Ph.D., Head of Research and Development, Shire. “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 2 study, two Phase 3 efficacy and safety studies, and one long-term Phase 3 safety study.
Lifitegrast is a novel small-molecule integrin inhibitor. It binds to the integrin LFA-1 (lymphocyte function-associated antigen-1), a cell surface protein found on leukocytes, and blocks the interaction of LFA-1 with its cognate ligand ICAM-1 (intercellular adhesion molecule-1). ICAM-1 is over-expressed in corneal and conjunctival tissues in dry eye disease. LFA-1/ICAM-1 interaction contributes to the formation of immunological synapses resulting in T-cell activation and migration to target tissues.
About Dry Eye Disease
As defined by the 2007 Dry Eye WorkShop (“DEWS”), sponsored by the Tear Film & Ocular Surface Society (TFOS), dry eye is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface. Dry eye, an often chronic and progressive ocular disease, is one of the most common complaints to eye care professionals, and represents a significant unmet medical need1, 2.
Shire enables people with life-altering conditions to lead better lives. Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs.
We focus on providing treatments in Rare Diseases, Neuroscience, Gastrointestinal and Internal Medicine and are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas, such as Ophthalmics.
THE “SAFE HARBOR” STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included in this announcement that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, that:
- Schaumberg DA, Sullivan DA, Buring JE et al. Prevalence of dry eye syndrome among US women. Am J Ophthalmol. 2003 Aug;136(2):318-26.
- Schaumberg DA, Dana R, Buring JE et al. Prevalence of dry eye disease among US men: estimates from the Physicians' Health Studies. Arch Ophthalmol. 2009 Jun;127(6):763-8
Posted: March 2015
- FDA Approves Xiidra (lifitegrast ophthalmic solution) for Dry Eye Disease - July 12, 2016
- U.S. FDA Acknowledges Receipt of Resubmission of Shire’s NDA for Lifitegrast for Dry Eye Disease in Adults - February 4, 2016
- Shire Resubmits New Drug Application for Lifitegrast to U.S. FDA - January 25, 2016
- Shire Receives FDA Complete Response Letter for Lifitegrast NDA and Plans to Respond with OPUS-3 Trial - October 16, 2015
- U.S. FDA Grants Priority Review to Lifitegrast NDA for the Treatment of Dry Eye Disease in Adults - April 9, 2015
- Shire Plans to Submit a New Drug Application to FDA for Lifitegrast for Dry Eye Disease in Adults - May 16, 2014
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