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Shire announces plans to submit dry eye disease NDA in early 2015
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Shire plans to submit a New Drug Application to the U.S. Food and Drug Administration for lifitegrast in first-quarter 2015, according to a recent company press release.
The compound, a small-molecule integrin antagonist, is a preservative-free topical eye solution designed to treat dry eye disease.
Lifitegrast has been studied in a large clinical development program of more than 1,800 patients and is believed to reduce inflammation by inhibiting lymphocyte function-associated antigen 1 and preventing its binding to intercellular adhesion molecule-1, which influences T-cell activation and cytokine protein release, according to the release.
“We’re fortunate to have lifitegrast and our compound for retinopathy of prematurity as two potential innovative ophthalmology treatments, and we have every intention of complementing these compounds with additional pipeline products to address significant unmet patient need in ophthalmics,” Flemming Ornskov, MD, Shire CEO, said in the release.
Shire also plans to assess the need for gathering additional clinical data to support U.S., and potentially international, regulatory submissions, according to the release.