Shire PLC (NASDAQ: SHPG) made waves Tuesday morning following a key U.S. Food and Drug Administration (FDA) approval. The company announced that the FDA has approved Xiidra (lifitegrast ophthalmic solution) 5%, a twice-daily eye drop solution indicated for the treatment of the signs and symptoms of dry eye disease in adult patients.

Keep in mind that Xiidra is the only prescription eye drop indicated for the treatment of both signs and symptoms of this condition. Shire expects to launch Xiidra in the United States in the third quarter of 2016.

Roughly 16 million adults in the United States are diagnosed with dry eye disease. An often chronic ocular disease, dry eye is associated with inflammation that may eventually lead to damage to the surface of the eye.

Flemming Ornskov, M.D., MPH, CEO, Shire, commented:

The approval of Xiidra marks a new day in treatment options for patients with dry eye disease, with the only prescription eye drop approved in the U.S. specifically to treat both the signs and symptoms of the condition. As Shire’s first FDA-approved medicine in ophthalmics, this significant milestone advances our goal of becoming the global leader in this category, where there are unmet patient needs. We have a robust ophthalmics pipeline, and we look forward to leveraging Xiidra as our entrée into the space as we continue to develop additional innovative eye care treatment options.

Edward Holland, M.D., Professor of Clinical Ophthalmology, University of Cincinnati, and a clinical trial investigator for Xiidra, added:

The clinical program supporting the approval of Xiidra is the largest for an investigational-stage dry eye disease candidate to date, including more than 2,500 patients. The clinical trial program design took into consideration many of the challenges of past dry eye research. It’s exciting to see Xiidra as the first prescription eye drop FDA-approved for both the signs and symptoms of the condition.

Shares of Shire were trading up about 3.5% at $192.72 on Tuesday, with a consensus analyst price target of $241.86 and a 52-week trading range of $147.60 to $270.63.

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