August 24, 2009
Phase 2 study of RX-10045 for the treatment of chronic dry eye syndromeResolvyx Pharmaceuticals announced positive data from its 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. The 28-day, randomized, multi-center, placebo-controlled study in 232 patients with moderate dry eye was designed to evaluate the safety, tolerability and efficacy of RX-10045 administered twice daily. This 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 produced a significant dose-dependent improvement from baseline in symptoms recorded in daily patient diaries. The improvement was observed across all symptoms evaluated in the study, including dryness, stinging, burning, grittiness, ocular discomfort and the composite of each patient's most severe symptom (Worst Symptom Score). RX-10045 was superior to placebo on the primary symptomatic endpoint of Worst Symptom Score (p < 0.02), as well as on several individual symptoms. The onset of symptom relief occurred within the first week of treatment, and symptoms continued to improve over the course of the 28-day study, suggesting the potential for even greater benefit with longer treatment durations. RX-10045 also produced a 75% reduction from baseline in CAE-induced staining of the central cornea (p < 0.00001), the primary sign endpoint in the study. This improvement was greater than that observed for placebo, the difference approaching statistical significance (p = 0.11). RX-10045 also produced a significant improvement in CAE-induced staining in the inferior cornea and in the composite of central and inferior cornea, which also approached statistical significance over placebo (p = 0.09).
RX-10045 is a synthetic analog of RvE1, a naturally occurring resolvin. RX-10045 has been shown to have potent anti-inflammatory and cell-survival benefits in laboratory testing.
For more information call (781) 541-5045 or visit www.resolvyx.com.