The combined clinical evidence from five trials supports the U.S. FDA approval of lifitegrast as a first-in-class medication for treating all signs and symptoms of dry eye disease, according to researchers at the Association of Research for Vision and Ophthalmology annual meeting.
Adults with dry eye disease were assigned to lifitegrast or placebo in five randomized, double-masked, placebo-controlled trials: four 12-week efficacy safety studies and a 1-year safety study.
This presentation summarized the full safety and efficacy data from an overall program of 2,500 enrolled subjects, according to Amir Shojaei, PharmD, PhD, in a follow-up interview with Primary Care Optometry News.
The key measures were the sign endpoint of inferior corneal staining score (ICSS) and symptom endpoints of eye dryness score (EDS) and visual-related function subscale of a symptom scale.
Lifitegrast improved ICSS vs. placebo in the phase 2 study, OPUS-1 and OPUS-3.
Lifitegrast reduced EDS vs. placebo in OPUS-2 and OPUS-3.
The OPUS-1 co-primary symptoms endpoint of visual-related function subscale and the OPUS-2 co-primary sign endpoint of ICSS did not achieve statistical significance, according to researchers.
“Overall, we targeted the signs and the symptoms across the program and showed that three of the four efficacy studies exhibited a significant impact on corneal staining improvement, and all four studies were able to show a favorable impact on symptom improvement vs. placebo,” Shojaei continued.
Adverse events were mostly mild or moderate, and none were serious ocular treatment-emergent events.
“We also had a specific tabulation of the data on the fellow eye, Shojaei said.
“The fellow eye data revealed that we are still impacting it in the same manner as the study eye, so overall it shows a very good prognostic indicator,” Shojaei said. – by Abigail Sutton
Shojaei A, et al. Lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease: Combined evidence from five randomized controlled trials. Presented at: Association of Research for Vision and Ophthalmology annual meeting; May 7-11, 2017; Baltimore.
Disclosure: Shojaei is an employee of Shire. Please see the abstract for all remaining authors’ relevant financial disclosures.
Editor's note: This article has been updated to clarify a quote in the eighth paragraph.