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New dry eye drug shows promising results
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PHOENIX – Lifitegrast, a T-cell antagonist, has been shown to significantly improve symptoms, discomfort and ocular dryness in phase 3 clinical trials, according to a presenter here at the American Academy of Optometry annual meeting.
Kelly K. Nichols, OD, MPH, PhD, FAAO, reported that lifitegrast ophthalmic solution 5% (SARcode Bioscience) was tested against placebo in more than 500 patients at multiple sites.
According to a press release from SARcode Bioscience Inc., the OPUS-1 is a prospective, randomized, double-masked phase 3 study that evaluated the efficacy and safety of lifitegrast compared to placebo for treating the signs and symptoms of dry eye disease. Five-hundred eighty-eight patients with dry eye at 13 U.S. sites were dosed twice a day for 12 weeks.
"Lifitegrast demonstrated superiority over placebo in the improvement of inferior and total corneal staining scores from baseline to week 12 (P = .0007 and P = .0148, respectively)," the release said.
"We are pleased that lifitegrast demonstrated impressive results in corneal staining parameters, since this has been historically challenging in the development of new therapies for patients with dry eye disease," Charles Semba, MD, chief medical officer of SARcode Bioscience, said in the press release.
According to Nichols, the corneal fluorescein score showed worsening in the placebo group and significant improvement in the trial arm. Symptoms of discomfort and ocular dryness also significantly improved, she said.
"This is a milestone in the development of a dry eye therapeutic that hasn’t been obtained before," she told attendees. "The symptom score was significant in addition to an objective sign. Confirmatory studies are underway."
According to the press release, the mean ocular discomfort and eye dryness scores were lower in the lifitegrast group than in the placebo group at week 12 (P = .0273 and P = .0291, respectively).
"It is especially encouraging that common symptoms of dry eye disease were also reduced," Semba added, "providing evidence that improvement of the ocular surface may ameliorate symptoms of the disease."
SARcode Bioscience reported no unexpected or serious ocular adverse events.
Some patients experienced burning and stinging after administration, Nichols said, but noted that the drop irritation occurred after patients were in a challenge chamber.
She explained: "Patients were challenged in a dry room for 90 minutes; they had to show worsening of signs in order to be enrolled.
Dr. Nichols described lifitegrast’s mechanism of action.
"Most would agree that dry eye has an inflammatory component," she said. "T cells have LFA-1 on their surface all the time. They bind to ICAM-1, which initiates the cytokine cascade. If you could stop the binding and subsequent T cell trafficking into affected tissue, you could reduce the inflammatory response in that tissue.
"Lifitegrast acts as ICAM-1 decoy and prevents the binding of LFA-1 to ICAM-1," she continued.
Nichols said lifitegrast is a new anti-inflammatory under development, "but you have to hold your breath; they need the results from the second phase 3 to parallel what they’ve seen in the first phase 3."
"Phase 3 will look at whether or not drop instillation irritation is a common occurrence…without the chamber challenge," she added.
The company said it began a year-long safety study (SONATA) and will soon begin the phase 3 confirmatory study (OPUS-2). "Both studies will support a planned New Drug Application filing," the press release stated. – by Nancy Hemphill, ELS
References:
Nichols KK, Semba C. Lifitegrast: A novel treatment for dry eye disease. Paper presented at Academy 2012; October 2012; Phoenix, AZ.
For more information:
Disclosures: Nichols is a consultant for, receives research support from and has stock options with SARcode Bioscience.