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Shire Aims to Refile Blockbuster Eye Drug in First Quarter

Shire Plc plans to resubmit its application for U.S. approval of a potential blockbuster drug for dry-eye disease next year after regulators unexpectedly asked for additional testing and information.

“We were disappointed" by the feedback on the medicine, called lifitegrast, Chief Executive Officer Flemming Ornskov said in a statement, adding that the Dublin-based drugmaker would soon get data from an advanced study called Opus-3 that may help with a re-submission to the U.S. Food and Drug Administration. Shire shares fell 1.7 percent to 4,433 pence at 8:13 a.m. in London.

Lifitegrast is one of the medicines in development that Shire is counting on to meet a goal of boosting sales to $10 billion by 2020...