Reproducible, statistically significant data shows that lifitegrast improves the signs and symptoms of dry eye, especially in the mild to moderate forms, along with a favorable safety profile, based on a literature review of the phase 2 and phase 3 OPUS studies.
Researchers in Clinical Ophthalmology discussed the design and clinical data supporting lifitegrast 5% ophthalmic solution.
The FDA requires two adequate and well-controlled trials demonstrating statistical significant improvement in both a sign and a symptom of dry eye disease (DED).
The phase 2 trial achieved statistical significance for corneal staining (sign), and the OPUS-1 trial replicated this result, according to researchers. However, symptom efficacy was not demonstrated in these trials.
OPUS-2 showed significance for improving eye dryness (symptom), which was confirmed by OPUS-3, they wrote. Upon completion of OPUS-3, both FDA criteria for drug approval had been met, according to the researchers.
SONATA was a multicenter, randomized, double-masked, placebo-controlled trial testing lifitegrast safety. A total of 504 patients were screened at 22 U.S. sites between October 2012 and March 2014.
A higher percentage of patients in the lifitegrast group had treatment-emergent adverse events compared to the placebo group.
The lifitegrast group had nearly twice the frequency of participants with reduced visual acuity than in the placebo group, but mean changes in best corrected visual acuity from baseline to day 360 were minimal in both groups, according to researchers.
Treatment discontinuation due to burning occurred in only two lifitegrast patients. No serious ocular adverse events occurred.
“Lifitegrast may be used in addition to other conventional dry eye therapies and will hopefully provide clinically meaningful improvement in this disease for many patients in the future,” researchers wrote. – by Abigail Sutton
Disclosure: Godin reports no disclosures. Gupta is a consultant to Shire.