Results of the LX211-01 study, which investigated LX211 in 218 patients with active, sight-threatening uveitis affecting the posterior segment of the eye, will also be presented at AAO on Monday October 26 at 9:00 am PT by clinical investigator Quan D. Nguyen, M.D., of the Wilmer Eye Institute at The Johns Hopkins University, Baltimore, MD. "In this study, also a double-masked, placebo-controlled, dose-ranging trial conducted in North America, Europe and India, control of inflammation was evaluated by means of change in vitreous haze at weeks 16 and 24. Results showed the LX211 presumed label dose of 0.4 mg/kg twice daily to be statistically significantly superior to placebo at both time points. Preservation of vision was also demonstrated in this study."
In explaining the overall clinical benefit, C. Stephen Foster, MD, President, Massachusetts Eye Research and Surgery Institution (MERSI), highlighted the ability of LX211 to control inflammation and to significantly delay recurrence of inflammatory exacerbation compared to the control group. Moreover, this result was achieved while successfully reducing corticosteroids to 5 mg/day or less. "Therapy with LUVENIQ conforms to the 2000 uveitis treatment guidelines, and is supported by randomized clinical trials that offer the highest level of evidence-based support. Once approved, LUVENIQ would be the only uveitis therapy so rated and thus, one that should always be offered," Dr. Foster stated in his presentation to the AUS on Sunday October 25 at 8:00 pm PT.
Treatment with LX211 was overall well tolerated at the twice-daily 0.4 mg/kg dose, demonstrating a safety profile that appears suitable for chronic use. Adverse effects on renal function (8.2% of subjects with decrease from baseline of ≥30% in glomerular filtration rate vs. 4.1 % in placebo) and blood pressure (mean increase in systolic BP by 6 mm Hg) were moder
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