US regulators have assigned Shire’s application to market experimental dry eye drug lifitegrast a Priority Review, thereby trimming its assessment time from the standard 12 months to just eight.
Representing a significant unmet medical need, dry eye is one of the most common complaints to eye care professionals. The condition is considered a multifactorial disease of the tears and ocular
surface causing discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface.
Lifitegrast, which Shire took under its wing through its $160-million acquisition of US group SARcode Bioscience in 2013, is a small-molecule integrin antagonist formulated in a preservative-free topical eye solution that has been studied in a programme of more than 1,800 patients.
The drug stands a good chance of becoming the first therapy approved to treat both the signs and symptoms of the chronic condition, and Shire is expecting peak sales of over $1 billion if it hits the market.
The FDA is expected to provide a decision by October 25.