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Novaliq's dry eye treatment yields positive topline results
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A preservative free cyclosporine A solution consistently reduced corneal fluorescein staining in a phase 2 clinical trial evaluating the treatment for moderate to severe dry eye disease, according to a press release from the manufacturer Novaliq GmbH.
The randomized, double-masked, vehicle-controlled, multicenter U.S. study enrolled 207 patients assigned to one of four groups: a 0.05% CyclASol group, a 0.1% CyclASol group, an open label active control group and a placebo group. Treatment lasted 4 months.
Compared with patients in the control and placebo groups, patients in the two cyclosporine A groups demonstrated a significant improvement in corneal staining, which was the primary sign endpoint, as well as onset of action as early as 14 days, according to the release.
“The role of cyclosporine A in resolving ocular surface inflammation has been well demonstrated and the novel CyclASol formulation may provide a promising new option for physicians and their patients suffering from moderate to severe dry eye disease,” Michael E. Stern, PhD, scientific advisory board member of Novaliq, said.