Shire finally gains FDA approval for delayed dry eye drug lifitegrast

Flemming Ornskov Shire CEO
Flemming Ornskov, CEO of Shire

Shire ($SHPG) has been given a key U.S. approval for its new eye disease drug lifitegrast nearly a year after it was rejected by the FDA, and can now look to make good on its expected blockbuster sales.

The Irish biopharma was hit with a complete response letter from the agency in October last year, with the FDA saying Shire had to do more clinical work and give it more assurances over the drug’s quality before it could gain an approval.

It already had an ongoing Phase III which ended late last year, and the company used this as the basis of its swift resubmission. Now, just a few months later, Shire has been given this much-needed approval for lifitegrast, marketed as Xiidra, which now has a license for the signs and symptoms of dry eye disease.

Launch will happen in the third quarter with analysts touting this as a potential blockbuster, with $1 billion in sales a year estimated at peak.

“The approval of Xiidra marks a new day in treatment options for patients with dry eye disease, with the only prescription eye drop approved in the U.S. specifically to treat both the signs and symptoms of the condition,” said Flemming Ornskov, CEO of Shire.

“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.”

Symptoms of dry eye disease vary by patient, but typically can include eye dryness, overall eye discomfort, stinging, burning, a gritty feeling and episodes of blurred vision. Around 16 million Americans are estimated to have the condition, according to Shire’s figures.

There are a number of treatments on the market for dry eye disease, including Allergan’s ($AGN) Restasis (cyclosporine) and other steroids--although Shire stresses that its drug is the first to treat both signs and symptoms of the disease, which it hopes will give it an edge, despite being later to market.

Wet age-related macular edema is likely a better known ailment and is led by Roche ($RHHBY)/Novartis’ ($NVS) Lucentis (ranibizumab) and Bayer/Regeneron’s ($REGN) Eylea (aflibercept)--both of which also have a host of other licenses and are making blockbuster sales. These drugs cannot, however, help patients with dry eye disease.

Shire will now hope to carve out a space in this market, although hot on its heels is Auven Therapeutics, which is testing a reformulated and what it hopes will be better version of Allergan’s Restasis (which makes around $1.3 billion a year). It is looking for a U.S. approval next year with a confirmatory Phase III study currently ongoing.

Getting its approval before Auven--and in fact at all after that CRL--is a real win for Shire, and one it needed given the effort being poured into its Ophthalmics Business Unit (OBU), which was set up just two years ago.

Xiidra, which Shire bought in 2013 with its acquisition of SARcode Bioscience, is the OBU’s leading light.

It has spent a lot of time and money on this Unit, buying up a number of companies over the past two years including Foresight Biotherapeutics, Premacure AB and BIKAM Pharmaceuticals as it looks to create and manage a growing ophthalmic pipeline.

- check out the release

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