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A novel investigational agent appears to help control uncomfortable symptoms of dry eye. The results of OPUS-I, a phase III randomized clinical trial, found that lifitegrast demonstrated superiority to placebo in reducing corneal fluorescein and conjunctival lissamine staining.
Seattle-A novel investigational agent appears to help control uncomfortable symptoms of dry eye. The results of OPUS-I, a phase III randomized clinical trial, found that lifitegrast demonstrated superiority to placebo in reducing corneal fluorescein and conjunctival lissamine staining.
These are primary clinical parameters of dry eye disease, said Charles P. Semba, MD, chief medical officer at SARcode Bioscience Inc.
“In the initial phase II trial, which led to the launch of OPUS-I, we found a reduction in staining,” Dr. Semba said. “Reductions in staining were associated with significant improvements in key symptoms.”
In the larger OPUS-I study, which was a 12-week, placebo-controlled trial, Dr. Semba explained that the goal was to see if there were benefits with the agent, as far as controlling signs and symptoms.
Lifitegrast is an investigational drug targeting the integrin lymphocyte antigen-1 (LFA-1) and inhibits binding to its cognate ligand, intracellular adhesion molecule-1 (ICAM-1) by serving as an ICAM-1 decoy. LFA-1/ICAM-1 interactions are key steps in regulating T-cell mediated inflammation.
The cohort consisted of 588 patients with dry eye disease, who were enrolled at 13 clinical sites across the United States.
As compared with placebo, lifitegrast demonstrated superiority by reducing inferior (p = 0.0007), superior (p = 0.0392), and total corneal staining (p = 0.0148), from baseline to day 84. These effects were also accompanied by significant improvements in nasal (p = 0.0039), temporal (p = 0.0936) and total (p = 0.0285) lissamine staining.
The onset of action was observed as early as Day 14 and maintained through Day 84.
“When we looked at the spontaneous relief of symptoms for eye dryness, they were statistically significant as early as week 6,” Dr. Semba said. The primary complaints of dryness and discomfort were significantly improved at Day 84 (p = 0.0291, p = 0.0273).
No significant changes were observed in IOP, best-corrected visual acuity, slit lamp, dilated fundoscopy, and corneal sensitivity.
There were also no unanticipated or serious ocular adverse events, Dr. Semba said. There were no serious ocular adverse events, and the most common side effect was with the initial dose of lifitegrast at Day 0.
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