Issue: June 2016
Perspective from Francis S. Mah, MD
May 09, 2016
1 min read

Lifitegrast improves patient-reported dry eye symptoms in OPUS-3 study

Issue: June 2016
Perspective from Francis S. Mah, MD
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NEW ORLEANS — Patients who were treated with lifitegrast for moderate to severe dry eye disease reported improvement in ocular symptoms, according to a study presented here.

“In dry eye subjects with moderate to severe baseline symptomology and a history of recent artificial tear use, lifitegrast significantly improved patient-reported symptoms as measured on the dry eye score,” Edward J. Holland, MD, said at the American Society of Cataract and Refractive Surgery meeting.

Edward J. Holland

OPUS-3 was a phase 3, multicenter, randomized, prospective, double-masked, placebo-controlled study including 711 patients with self-reported dry eye disease who had a history of artificial tear use within 30 days of the study; 355 patients were administered lifitegrast (Shire), and 356 patients were administered placebo.

The primary endpoint of the study was change in eye dryness score from baseline to day 84.

Holland reported a significant improvement in eye dryness score for the lifitegrast group compared with the placebo group at day 84 (P = .0007). Additionally, there was a significant improvement in key secondary endpoints of change in eye dryness score at day 14 and day 42 for the lifitegrast group compared with the placebo group (P = .0001).

Symptom improvement in the lifitegrast group was “virtually identical” when comparing results from the OPUS-2 and OPUS-3 studies, Holland said.

Lifitegrast was generally well tolerated by patients.

“There were no serious ocular treatment emergent adverse events. Almost all the events were considered mild in severity,” Holland said.

In the lifitegrast group, the most common reported events were instillation site burning (18%), instillation site reaction (12.5%) and dysgeusia (13%).

Drop comfort in the lifitegrast group improved within 3 minutes of instillation and showed consistent reduction across visits, Holland said.

“The results of OPUS-3 replicated the symptom improvement results observed in OPUS-2,” he said. – by Nhu Te


Holland E. Results of a phase 3 trial of lifitegrast for the treatment of dry eye disease. Presented at: American Society of Cataract and Refractive Surgery meeting; May 6-10, 2016; New Orleans.

Disclosure: Holland reports he is a consultant for Shire. The study was funded by Shire.