Four clinical trials
Lifitegrast was evaluated over 4 clinical trials in over 2,200 patients, including 3 phase III trials with about 2,000 patients. Trials evaluated safety and efficacy, including the safety of the vehicle. Signs of dry eye were evaluated using corneal staining and symptoms using the standard dryness score.
The average baseline dryness score at baseline was between 40 and 70 on a 100-point scale. A statistically significant reduction in dryness score favoring lifitegrast was seen in all 4 studies at week 6 and week 12.
Symptom improvement was noted in as little as 2 weeks in 2 studies. There was a statistically significant reduction in corneal staining at 12 weeks in 3 of the 4 studies.
Shire has already filed for lifitegrast marketing approval in Canada and plans filings in multiple global markets by the end of 2017. The company is also developing new products for other ophthalmic indications.
“We have a high level of commitment from our CEO and board of directors to become a major player in the ophthalmic space,” Dempsey said. “Our core focus is the new chemical entities that will address those significant unmet needs in the ophthalmic space.”