"There is an urgent need for new treatment options in dry eye and the results of this Phase 2 study are as strong as any I have seen," said Stephen Pflugfelder, MD, an expert in dry eye at Baylor College of Medicine. "Based both on these clinical results and on its unique mode of action, I am confident that RX-10045 can be an important new treatment modality for these patients."
The 28-day, randomized, multi-center, placebo-controlled study in 232 patients with moderate dry eye patients was designed to evaluate the safety, tolerability and efficacy of RX-10045 administered twice daily. 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.
"I am very encouraged by the symptom relief achieved with RX-10045," said Ira Udell, M.D., Chairman of the Department of Ophthalmology at the North Shore-Long Island Jewish Health System and Professor of Ophthalmology and Visual Sciences, Albert Einstein College of Medicine. "Symptomatic improvement is what really matters to patients."
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).
"We are very enthusiastic about the results of this Phase 2 study both as a demonstration of the potential of RX-10045 to treat dry eye patients and as the potential of the entire resolvin class to treat a range of inflammatory diseases," said Greg Weinhoff, Executive Chairman of Resolvyx. "The results of this study will help Resolvyx design the pivotal trials for RX-10045, which are currently targeted to begin in the first half of 2010."
Resolvyx is also currently conducting a Phase 1 study with a second resolvin, RX-10001, an orally-administered drug candidate for the treatment of systemic inflammatory diseases such as asthma, inflammatory bowel disease and other inflammatory diseases.
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