Shire says it has re-filed its eye drug liftegrast with regulators in the US, after the therapy was rejected following a priority review back in October.
The US Food and Drug Administration had asked for more information on its use to treat the signs and symptoms of dry eye disease, one of the most common complaints to eye care professionals for which there remains high unmet medical need.
At the time, Shire said it was confident of being able to address the issues raised quickly, with the basis of its response coming from the newly-completed OPUS-3 Phase III study.
Data from this efficacy and safety study - which had a primary endpoint of patient-reported symptom improvement - has now been submitted to the FDA, alongside information on product quality requested by the regulator, the firm said.
“The NDA for lifitegrast now includes data from five randomised controlled clinical trials, with more than 2,500 patients, making it the largest data set for an investigational stage compound in dry eye disease to date,” noted Philip Vickers, head of R&D at Shire. “Because we believe that, if approved, lifitegrast has the potential to help the millions of US adults living with symptoms of dry eye disease, we worked diligently to submit our response to the CRL as quickly as possible”.
Shire acquired the drug through its $160-million take-over of US group SARcode Bioscience in 2013, and is expecting peak sales of more than $1 billion if it makes it to market.