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Shire Receives Long-Awaited Approval For Dry Eye Drug

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While patients with dry eye disease already have multiple treatment options – including Allergan’s Restasis (cyclosporine) – Shire says that its drug is the only treatment that addresses both the signs and symptoms of the condition.

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July 13, 2016 | by Sarah Massey, M.Sc.

Almost one year after being rejected by the US Food and Drug Administration (FDA), Shire’s dry eye disease drug, lifitegrast, has finally received regulatory approval. The biopharmaceutical company is now looking ahead to the drug’s blockbuster sales potential.

In October of 2015, the FDA issued a complete response letter to Shire, requiring the company to perform more clinical trials before the drug could be considered for approval. At the time, Shire was already conducting a Phase III clinical trial which concluded just before the end of the year.

The company used this data to file a quick resubmission for lifitegrast to the FDA. Now that the drug has gained regulatory approval for the indication of treating the signs and symptoms associated with dry eye disease, Shire will market lifitegrast under the name Xiidra.

Analysts have already begun to estimate the drug’s annual sales at a potential $1 billion per year at its peak. This potential blockbuster drug will be launched in the third quarter of this year.

“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.”



Common symptoms of dry eye disease including eye dryness, stinging, burning, blurred vision and general eye discomfort. According to Shire, approximately 16 million people in the US are affected by the eye condition.

While patients with dry eye disease already have multiple treatment options – including Allergan’s Restasis (cyclosporine) – Shire says that its drug is the only treatment that addresses both the signs and symptoms of the condition. Despite their late entry onto the market, Shire hopes the drug will be a best-seller.

Auven Therapeutics is also looking to enter the dry eye disease space with its reformulated version of Allergan’s Restasis. While the drug is still in clinical trials, Auven has high hopes for the treatment as Allergan’s version brings in about $1.3 billion in sales every year.

Auven anticipates that it will be filing for FDA approval sometime in 2017, as a Phase III clinical trial of the drug is still underway. Shire’s dry eye drug approval is a big win for the company’s Ophthalmics Business Unit (OBU), which was established two years ago.


Keywords: FDA, Blockbuster, Eye Disease


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