StemCell Therapy

Irish biotech giantShire plc (LON:SHP) received a validation fromthe UK, in the capacity of the Reference Member State, for its marketing authorization application forlifitegrast. If approved, lifitegrast would be the first and only treatment in a new class of drugs (LFA-1 antagonist) to address the signs and symptoms of dry eye disease in adults in Europe, said the company.

Shire submitted the application for marketing authorization (MAA) through a Decentralized Procedure toDenmark, Norway, Sweden, Finland, the UK, Germany, the Netherlands, France, Italy, Portugal, Spain and Greece.This submission is another important milestone for lifitegrast and the millions of patients living with dry eye disease, which can impact a persons vision-related quality of life, affecting daily activities such as reading and using computers, commented Shires head of clinical department Howard Mayer.

Opthalmology hasnt been at the core of Shires growth agenda historically, but its acquisition of SARcode Bioscience in 2013 marked an official entry into the medical field, where Shire expects to capitalise on unmet needs in eye care through a multi-faceted approach targeting rare diseases and specialty conditions.

Shires MAA forlifitegrast is backed by what the company claims to be the largest development program to date for an investigational stage dry eye disease candidate. The program involves five clinical trials with 2,500 patients. In four safety and efficacy studies, lifitegrast improved symptoms as measured by patient reported eye dryness score (EDS), and in three of the four studies improved the objective signs of dry eye disease (measured using corneal staining), said Shire.

Nearly a year ago, llifitegrast received the US FDA approval as Xiidra for dry eye treatment. Out of more than US$14 billion in sales over the past year, Xiidra accounted for just over $50 million (representing a more than 20% market share in the US) with opthalmology contributing 2% to overall sales, which largely comprises of five therapeutic areas: Hemtology, Genetic Diseases, Immunology, Neuroscience and Internal Medicine.

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Shire PLC (SHP): Looking To Captalise On Unmet Needs In Eye Care - Simply Wall St

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