CyclASol improves ocular surface staining, tear production
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WASHINGTON — CyclASol, a novel nonaqueous cyclosporine eye drop, demonstrated improvements in the signs of dry eye disease, according to a study.
At the American Society of Cataract and Refractive Surgery meeting, John Sheppard, MD, said many patients with dry eye are affected by damage to the central epithelium
“There is destruction of corneal epithelial tissue that leads to the signs and symptoms of most of our patients with dry eye disease,” he said. “Targeting this specific characteristic of dry eye has become the centerpiece of so many potential therapeutic interventions.”
The ESSENCE-2 trial included 834 patients with dry eye disease who were randomly assigned to receive CyclASol (Novaliq) or vehicle bilaterally twice daily for 29 days.
The primary sign endpoint was change from baseline in total corneal staining, while the primary symptom endpoint was change from baseline in eye dryness score at day 29.
Patients in the CyclASol group experienced a greater reduction in total corneal staining compared with vehicle (P = .0278). Sheppard said 71.6% of patients showed response in total corneal staining.
Although CyclASol showed a treatment benefit in eye dryness score, the difference was not statistically significant, Sheppard said.
A greater percentage of patients in the CyclASol group had a Schirmer’s test increase of at least 10 mm compared with the vehicle group (P = .0487).
Sheppard said that some patients reported treatment-emergent adverse events, including 16.8% in the drug group and 17.8% in the vehicle group.
“There is an early onset of action as early as 15 days,” Sheppard said. “This was improving tear production at 4 weeks. There was superior blurred vision relief in high central staining patients, and the safety and tolerability profiles were acceptable.”
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Sheppard J. Efficacy and safety of a non-aqueous cyclosporine formulation for the treatment of dry-eye disease: The ESSENCE-2 trial. Presented at: American Society of Cataract and Refractive Surgery meeting; April 22-26, 2022; Washington.
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