Shire Reports Positive Phase 3 Trial Results For Lifitegrast Drug

Specialty biopharmaceutical company Shire has announced positive results from a Phase 3 OPUS-2 study on its lifitegrast ophthalmic solution. The study measuring the safety and effectiveness of lifitegrast being administered twice a day was randomized, double-masked, placebo-controlled, and lasted a year. The clinical trial met one of its primary endpoints of reduced dry eye symptoms in comparison to the placebo. However, the study did not meet its second co-primary endpoint of the sign of inferior corneal staining.

Lifitegrast was developed to treat adults who are suffering from dry eye disease. It works by reducing inflammation inside of the eye. The results of the study were presented at the 2014 American Society of Cataract and Refractive Surgery (ASCRS).

Phil Vickers, head of research & development with Shire, said that the company’s next steps were to meet with the FDA. “These clinical trials are part of a large Phase 3 clinical program with more than 1,600 patients,” said Vickers. “We look forward to meeting with the FDA to discuss the totality of data for lifitegrast, which will help us determine our path forward.”

Joseph Tauber of the Tauber Eye Center in Kansas City said it was encouraging that there were new drugs in the works for dry eye disease, given that so many adults complain of symptoms. “Symptoms of dry eye are certainly the most common complaints that I hear from patients in my practice,” said Tauber. “Patients come in seeking relief from their chronic and sometimes debilitating symptoms. It’s encouraging that potential new treatment options are being developed for dry eye disease, which affects millions of people in the U.S.”

Shire also stated that there were no adverse effects associated with its lifitegrast treatment. The most typical side effect reported by patients using the solution was a changed sense of taste and some irritation of the application site.