Just over two years after entering the ophthalmic market, international biotechnology company Shire has gained FDA approval for Xiidra, a lifitegrast ophthalmic solution for the treatment of dry-eye disease.Shire chief executive officer Dr Flming Ornskov said the development was significant as Xiidra was the only prescription eye drop approved in the US specifically to treat both the signs and symptoms of the condition . 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, he added.A FiercePharma report suggested Xiidra could potentially steal market share from Allergan’s Restasis product, noting that the established cyclosporine eye drops were only indicated for tear production whereas its new competitor had a full dry-eye label.Bernstein analyst Mr Ronny Gal reportedly pointed out, though, that while Shire has a labelling advantage, Allergan enjoys the power of incumbency , including contracts, sales and an established patient pool.Another analyst, Evercore ISI’s Mr Umer Raffat, was cited as saying that even if Xiidra did take some of Restasis’ market share – he estimated it would be approximately 30 per cent – Allergan would likely be able to offset about 10-15 per cent through a series of price increases.Xiidra will be launched in the US in the third quarter of 2016.
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