Shire to submit new drug application to FDA for dry eye disease

Lexington, MA-Shire recently announced its plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lifitegrast for the treatment of dry eye disease in adults in first-quarter 2015. 

As it prepares to submit the NDA, Shire will also assess the need to gather additional clinical data in support of the U.S. and potential international regulatory submissions.

According to Shire, Lifitegrast is “an investigational treatment that has been studied in a large clinical development program of more than 1,800 patients. The compound, a small-molecule integrin antagonist, was designed to treat dry eye disease, and is a preservative-free topical eye solution. Lifitegrast is believed to work by reducing inflammation through inhibition of lymphocyte function-associated antigen 1 (LFA-1) and preventing its binding to intercellular adhesion molecule-1 (ICAM-1) that influences T-cell activation and cytokine (protein) release. The interaction between these two proteins plays a key role in the chronic inflammation associated with dry eye. T-cells are important components of the immune system that help control the body's response to a foreign or harmful substance or stimuli.”

In related news, the company announced it would create an Ophthalmic Business Unit to focus on the commercialization of its ophthalmic pipeline products. Robert Dempsey, formerly of Bausch + Lomb, was hired to run the unit. The company also hired Reza Haque, MD, PhD, also formerly of Bausch + Lomb, as therapeutic area head for ophthalmology. Dr. Haque will oversee the lifitegrast and Phase 2 retinopathy of prematurity clinical development programs, in addition to any future ophthalmic programs. 

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