Oral anti-inflammatory significantly improves dry eye signs and symptoms

Ophthalmol. 2010;117(7):1287-1293.

An oral adenosine receptor agonist proved safe, effective and tolerable as a treatment for moderate to severe dry eye syndrome, a study showed.

Investigators conducted the phase 2, multicenter, randomized, controlled study to gauge the safety and efficacy of CF101, an A₃ adenosine receptor agonist known to yield a significant anti-inflammatory effect. The agent is also associated with tumor necrosis and inhibition of autoreactive T-cell proliferation, the study authors said.

"The concept of treating dry eye syndrome with an oral drug is based on much better patient compliance than that associated with a topical treatment," they said. "The use of CF101 for the treatment of dry eye syndrome was enabled based on its apparent safety profile and continued anti-inflammatory effect for a long period, up to 18 months."

The study included 33 patients assigned to CF101 treatment and 35 patients assigned to a placebo comparator group. Mean patient age was 52.56 years in the treatment group and 61.73 in the placebo group.

Patients were treated orally with 1-mg CF101 pills or matching vehicle-filled placebo pills twice daily for 12 weeks. Patients were observed for 2 weeks after cessation of treatment.

The primary efficacy endpoint was the rate of 25% or more improvement over baseline at 12 weeks in tear breakup time, superficial punctate keratitis assessed by fluorescein staining or Schirmer tear test 1 results.

Primary safety endpoints were the nature, severity and duration of observed adverse events, and results of clinical laboratory safety testing.

Results showed that patients in the CF101 group had a statistically significant improvement in corneal staining, tear breakup time and tear meniscus height. In addition, CF101 patients had a statistically significant decrease in IOP, the authors reported.

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