Shire launches potential blockbuster dry eye drug in US

Shire has launched its dry eye treatment Xiidra (lifitegrast) in the US, a drug the company hopes will achieve blockbuster status.

The Dublin-based, London-listed company said Xiidra is available as a twice daily eye drop for signs and symptoms of dry eye disease.

Ophthalmology is likely to be a key area for Shire, which acquired Xiidra through its $160 million buyout of SARcode Bioscience in 2013.

Last year Shire boosted its ophthalmology pipeline, paying out $300 million for Foresight Biotherapeutics and a conjunctivitis drug.

Shire's management hopes Xiidra will generate annual sales of more than $1 billion, thanks to a large patient of population of 16 million people in the US alone, although it will compete with Allergan's older Restasis (cyclosporin).

The US Food and Drug Administration initially rejected Xiidra in October last year, asking for an additional study.

Luckily for Shire, its OPUS-3 phase 3 trial had just been completed, which provided the FDA with the data it required.

After refiling in January with the OPUS-3 data, the FDA approved Xiidra last month.

Xiidra is the first in a new class of drugs – a lymphocyte function-associated antigen 1 (LFA-1) antagonist.

It binds to the integrin lymphocyte function-associated antigen-1 (LFA-1), a cell surface protein found on leukocytes, and blocks the interaction of LFA-1 with its cognate ligand intercellular adhesion molecule-1 (ICAM-1). ICAM-1 may be overexpressed in corneal and conjunctival tissues in patients with dry eye disease.

However the exact mechanism of action of lifitegrast is unknown.

Perry Sternberg, Shire's US commercial head, said: “Shire worked rapidly to bring Xiidra to market following the approval of this new treatment – a first-in-its-class medication and the first prescription treatment to be approved for both the signs and symptoms of dry eye disease.”

“We have a full range of modern, educational access programmes to support the millions of patients across the US living with dry eye disease. This delivers on our commitment to showing up differently in ophthalmics.”