Oct 16 (Reuters) - The U.S. Food and Drug Administration notified Shire Plc it will not approve its eye drug Lifitegrast, the company said on Friday, adding that the U.S. health regulator recommended the company conduct additional clinical studies.

Shire said it received a complete response letter, which the FDA sends to let a drug developer know a marketing application will not be approved in its present form.

Shire had submitted a marketing application for the drug in treating patients with dry eye disease, the company said in a statement.

A decision on the drug's approval was expected by October 25.

(Reporting by Rosmi Shaji in Bengaluru; Editing by David Gregorio)