The Dry Eye Zone

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Drug news: Resolvyx RX10045 positive results

Good news for Resolvyx on its fish oil derivative eye drop:

Resolvyx Reports Positive Results For Phase 2 Clinical Study Of RX-10045

Resolvyx has reported positive data from a phase 2 clinical study evaluating RX-10045, a resolvin administered as a topical eye drop for the treatment of patients with chronic dry eye syndrome.

In the 28-day, randomized, placebo-controlled, 232-patient trial, RX-10045 produced dose-dependent, improvement on the primary endpoints for both the signs and symptoms of dry eye. Alos, it was shown to be safe and well tolerated, said the company.

The phase 2 study examined three doses of RX-10045 and utilized a controlled adverse environment (CAE) to measure corneal staining in a stressful drying environment, as well as daily patient diaries using a standard visual analog scale to assess symptom improvement over the course of the study.

RX-10045 was superior to placebo on the primary symptomatic endpoint of Worst Symptom Score, as well as on several individual symptoms. The onset of symptom relief occurred within the first week of treatment and continued to improve over the course of the 28-day study, suggesting the potential for even greater benefit with longer treatment durations.
Moreover, RX-10045 also produced a 75% reduction from baseline in CAE-induced staining of the central cornea, the primary sign endpoint in the study. The improvement was greater than that observed for placebo, the difference approaching statistical significance.