Shire Working To Submit FDA Application For Dry Eye Disease Drug

Shire, an Irish pharmaceutical company located in Massachusetts, has announced that the company is currently preparing to submit a new drug application to the FDA for its dry eye disease drug candidate. The drug is called lifitegrast, and Shire plans to submit the new drug application in early 2015. The company will be forming a business unit to work on the commercialization of its eye disease pipeline as the company makes the preparations to submit its drug application to the FDA.

Flemming Ornskov, CEO of Shire, says, “As we prepare for the FDA submission, we will also form an Ophthalmics Business Unit (BU) that will focus on the commercialization of our ophthalmic pipeline products. This BU will be led by Robert Dempsey, who we recently hired from Bausch & Lomb. Bob has more than 20 years of experience in eye care and has been instrumental in the launches of several well- known eye care products.”

Dempsey went on to name Perry Sternberg, Head of the Neuroscience BU, and Reza Haque, Therapeutic Area Head for Ophthalmology, as people who will play critical roles in the coming months for the company. The company is optimistic that lifitegrast will be granted FDA approval in early 2015.

Shire has been in the news recently, as just last week, the company announced that it had acquired Lumena Pharmaceuticals, a company which specializes in developing drugs for rare gastrointestinal diseases.

The company also plans to gather more clinical data on the drug’s performance in support of the U.S and potential international regulatory submissions. Lifitegrast has been tested in clinical studies with an enrollment of 1,800 patients. The drug, a small-molecule integrin antagonist, is administered as a topical eye solution which prevents certain proteins in the eye from bonding, in turn reducing inflammation in the eye.