Shire dry eye drug approved in US

Shire’s potential blockbuster Xiidra (lifitegrast) has been approved in the US for dry eye disease, bouncing back from a rejection by the regulator late last year.

Xiidra, in a 5% solution formulation, is indicated for signs and symptoms of dry eye disease in adults, and is the only prescription eye drop approved for this use.

The US Food and Drug Administration rejected Xiidra in October, asking for more trial data and further product quality information.

At the time, Shire said that data from the phase 3 OPUS-3 study would form the basis of its response. The FDA has now accepted this data and approved it.

Shire added lifitegrast to its pipeline through its 2013 acquisition of SARcode Bioscience, a privately held Californian biotech.

The drug is a significant part of a Shire plan to generate $10 billion a year in product sales by 2020, and could push through the billion dollar sales boundary by then.

Despite the delay, Xiidra will be the first to market in this indication when it is launched in the coming months, although Allergan is developing a rival.

In November last year, Allergan licensed in late-stage development drug tavilermide from Mimetogen Pharmaceuticals for dry eye disease, paying $50m upfront, funding further phase 3 development, plus milestone payments and royalties on sales.

This will be Shire’s first foray into ophthalmology and CEO Flemming Ornskov said there were further eye products in the pipeline to follow.

Shire is developing SHP607, a protein for prevention of Retinopathy of Prematurity, which is in phase 2.

It also has SHP640 for infectious conjunctivitis in phase 2 and has glaucoma and retinitis pigmentosa drugs in preclinical development.

Orsnkov said: “As Shire’s first FDA-approved medicine in ophthalmics, this significant milestone advances our goal of becoming the global leader in this category, where there are unmet patient needs.

“We have a robust ophthalmics pipeline, and we look forward to leveraging Xiidra as our entrée into the space as we continue to develop additional innovative eye care treatment options.”