Shire is to submit its dry eye drug lifitegrast for approval in the USA early next year and will form an ophthalmics business unit.
The move comes at a time when Shire is looking to diversify its offerings and it got hold of lifitegrast -through its $160 million acquisition last year of the USA’s SARcode Bioscience. The compound is a small-molecule integrin antagonist and is a preservative-free topical eye solution that has been studied in a programme of more than 1,800 patients.
Clinical data on lifitegrast has been mixed and last month Shire published data from a Phase III trial which showed that the drug met one goal for patient-reported symptoms of dry eye compared with placebo, but did not meet a second target based on signs of corneal staining. The company says it is now completing “remaining chemistry and manufacturing work” ahead of the submission and “will be assessing the need for gathering additional clinical data”.
Chief executive Flemming Ornskov noted that the company has hired two senior executives from eye specialist Bausch & Lomb to head the unit, which is also working on a Phase II compound for retinopathy of prematurity (ROP), a potentially blinding eye disorder affectting tiny babies.
