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

Issue: June 2016

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.

Perspective from Francis S. Mah, MD

“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

Reference:

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.

Perspective

Francis S. Mah, MD

The critical aspect is that in an FDA clinical trial, this drug has shown that it can statistically significantly reduce the symptoms of dry eye and in a rather short time. No. 2 is that, of all the drugs that have come through in clinical trials for dry eye in the past 15 years, we may have another FDA-approved medication added to the armamentarium to benefit our patients with dry eyes. Hopefully the medication will be FDA approved so that we have access to it and our patients will benefit from another medication. If approved, we will really be able to see the clinical significance.

Francis S. Mah, MD

OSN Cornea/External Disease Board Member

Disclosures: Mah reports he is a consultant for Allergan and Shire.