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Study shows lifitegrast reduces dryness, discomfort
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DENVER – Patients treated with lifitegrast showed improvement in symptoms but not signs of dry eye, according to a presenter here at the American Academy of Optometry meeting.
Paul M. Karpecki, OD, FAAO, presented results of OPUS-2, a phase 3 multicenter, randomized, double-masked, placebo-controlled trial of lifitegrast, an ICAM-1 decoy that targets chronic inflammation in dry eye disease.
Karpecki and colleagues randomized 718 adult subjects to topical lifitegrast 5.0% or placebo twice daily for 84 days after a 14-day placebo run-in period. Co-primary efficacy endpoints included inferior corneal staining and eye dryness, and secondary endpoints included the signs of total corneal staining and nasal lissamine staining and the symptoms of ocular discomfort and eye discomfort, according to the study abstract.
No differences were seen in the groups in inferior corneal staining, the researchers reported. The treatment group experienced significantly greater mean reduction in eye dryness. No differences were seen for the secondary sign endpoints. However, ocular and eye discomfort improved more in those treated with lifitegrast.
The researchers concluded in the abstract that subjects treated with lifitegrast “experienced significant improvement in the co-primary symptom endpoint but not the co-primary sign endpoint vs. placebo-treated subjects. Secondary outcomes in signs and symptoms consistently supported co-primary endpoints.”
"What was significant about the OPUS-2 study was that lifitegrast showed a statistically significant improvement in the prespecified symptoms of dry eye disease and was the first drug to do so in a phase 3 clinical trial,” researcher Paul M. Karpecki, OD, FAAO, told
The researchers also noted that the drug was well tolerated.
Disclosure: Karpecki is a paid consultant to Shire Pharmaceuticals and received a research grant for involvement as a principal investigator the lifitegrast phase 3 U.S. Food and Drug Administration clinical trials