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Lifitegrast appears safe, well-tolerated in dry eye patients

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SAN DIEGO — A new treatment for dry eye disease showed a high safety profile compared with placebo, according to a study presented here.

At the World Cornea Congress, Eric D. Donnenfeld, MD, reviewed results of the SONATA study, a 1-year phase 3 multicenter, randomized, placebo-controlled clinical trial examining lifitegrast ophthalmic solution 5% (Shire) in patients with dry eye.

Eric D. Donnenfeld

“Lifitegrast ophthalmic solution 5% twice a day for 365 days appears safe and well-tolerated with no unexpected adverse events,” Donnenfeld said. The SONATA study supports the favorable safety profiles seen earlier in the OPUS1 and OPUS2 trials.

Lifitegrast is a novel, first-in-class, small-molecule integrin antagonist designed to reduce inflammation.

The SONATA study included 221 patients who received lifitegrast and 111 patients who received placebo. Mean patient age was 61 years in the placebo group and 58 years in the lifitegrast group.

Investigators evaluated the safety of lifitegrast based on the percentage and severity of ocular and non-ocular events.

Secondary measures were ocular safety, corneal fluorescein staining, drop comfort, best corrected visual acuity, slit lamp biomicroscopy, IOP and dilated fundoscopy findings.

Adverse events occurred in 53.6% of patients in the lifitegrast group and 32.4% of patients in the placebo group.

"The percentage of treatment-emergent adverse events was higher in the lifitegrast group vs. the placebo group, but most notably there were no serious ocular adverse events,” Donnenfeld said. “Discontinuation due to adverse events was infrequent, with burning causing discontinuation in only two patients, or 0.9% of the population. There was no indication of systemic toxicity or complications due to local or systemic immunosuppression. Other ocular safety parameters were similar to placebo.”

The FDA granted lifitegrast priority review status on April 9. – by Matt Hasson

Disclosure: Donnenfeld reports he is a consultant for Shire.