LONDON Drugmaker Shire said it planned to submit for approval to the FDA, the U.S. drug regulator, a treatment for the symptoms of dry eye disease in the first quarter of next year, as part of its efforts to diversify its portfolio.
The product - Lifitegrast - has had mixed results in clinical trials so far. In April, the product met one goal for patient-related symptoms of the dry eye condition but failed on another.
"As we prepare for the FDA submission, we will also form an Ophthalmics Business Unit that will focus on the commercialization of our ophthalmic pipeline products," said Shire's chief executive Flemming Ornskov.
Lifitegrast - a potential competitor for Allergan's Restasis, which is expected to have sales of around $900 million this year - is viewed as a key new product for Shire as it seeks to diversify its product line-up.
Amid a wave of pharmaceuticals sector consolidation, Shire has reportedly attracted the interest of Allergan.
(Reporting by Sarah Young; Editing by Paul Sandle)