New dry eye drug shows promising results in clinical trials
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 Academy 2012.
Kelly K. Nichols, OD, PhD, FAAO, reported that lifitegrast 5% (SARcode Bioscience) was tested against placebo in more than 500 patients at nine sites.
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 said. “The discomfort score was significant.”
Nichols said lifitegrast is a new anti-inflammatory under development, “but you have to hold your breath; they need the results from the phase 3 to parallel what they’ve seen in the first phase 3. It’s close, but still not approved.”
Some patients experienced burning and stinging after administration, she 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.
“Phase 3 will look at whether or not drop instillation irritation is a common occurrence…without the challenge chamber,” she added.
Disclosures: Nichols is a consultant for, receives research support from and has stock options with SARcode Bioscience.