Ireland-based Shire is planning to submit a new drug application (NDA) for lifitegrast to the US Food and Drug Administration (FDA) in the first-quarter of 2015.
The company is seeking FDA approval for lifitegrast as a treatment for the signs and symptoms of dry eye disease in adults.
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Separately, the company will be evaluating the need for gathering additional clinical data in support of the US and potential international regulatory submissions.
Shire CEO Flemming Ornskov said as the company prepares for the FDA submission, it will also form an ophthalmics business unit (BU) that will focus on the commercialisation of its ophthalmic pipeline products.
"This BU will be led by Robert Dempsey, who we recently hired from Bausch & Lomb," Ornskov said. "Bob has more than 20 years of experience in eye care and has been instrumental in the launches of several well-known eye care products."
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"As we build out the BU, Bob will report to Perry Sternberg, head of the neuroscience BU, who also has ten years of ophthalmology experience."
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By GlobalData"Additionally, on our clinical development team, we have hired Reza Haque, MD, PhD, as therapeutic area head for ophthalmology, also from Bausch & Lomb.
"Reza will be responsible for overseeing the lifitegrast and the Phase II retinopathy of prematurity (ROP) clinical development programmes, and any future programmes in ophthalmics."
Lifitegrast is a small-molecule integrin antagonist and is a preservative-free topical eye solution that has been studied in a clinical development programme of more than 1,800 patients.
It 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 the two proteins plays a major role in the chronic inflammation associated with dry eye.
T-cells are major components of the immune system that help control the body’s response to a foreign or harmful substance or stimuli.
