OPUS-2: Lifitegrast improves symptoms but not signs of dry eye disease
BOSTON — Of two co-primary endpoints of the OPUS-2 study, signs and symptoms of dry eye disease, one was met and one was not, according to a speaker here.
“The study robustly met the primary endpoint for symptom, with a P value of .0001; however, there was no statistically significant difference for the endpoint sign of corneal staining,” Joseph Tauber, MD, said at the American Society of Cataract and Refractive Surgery annual meeting.
OPUS-2 is a phase 3 multicenter randomized double-masked placebo-controlled trial of 14 weeks’ duration, including a 2-week placebo run-in. Seven hundred eighteen adults with moderately symptomatic dry eye disease were randomized one to one to receive twice-daily placebo or lifitegrast ophthalmic solution 5% (SARcode Bioscience). During the study treatment, no use of artificial tears was allowed except for the study treatment.
Secondary symptom endpoints of ocular discomfort scores also “robustly supported or echoed” the findings of the primary symptom endpoints, Tauber said.
“These treatment benefits were evident by day 14 and continued out to day 84,” Tauber said.
However, there was no evidence of a significant lifitegrast drug response in any of the endpoint staining parameters or in Schirmer’s tear testing, he said.
“Tertiary endpoints showed a consistent lifitegrast benefit for a total score in all three subscales of the [Ocular Surface Disease Index],” Tauber said. “Of note, the vision-related OSDI endpoint, which had been the primary symptom endpoint in OPUS-1, showed the same statistically significant benefit.”
For the visual analog scale, with one exception of burning and stinging, all parameters showed an effect of lifitegrast over placebo, he said.
Lifitegrast is well tolerated, and no serious adverse events were observed, Tauber said.Disclosure: Tauber has received research funding and/or travel funding from SARcode Bioscience, a subsidiary of Shire, and from EyeGate, Acucela, Allergan, Eleven Biotherapeutics, Biolase, Xoma and Auven Therapeutics.