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P. Sternberg, P. J. Rosenfeld, J. S. Slakter, J. M. Koester, A. Reaves; Topical OT-551 for Treating Geographic Atrophy: Phase II Results. Invest. Ophthalmol. Vis. Sci. 2010;51(13):6416.
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To determine if treatment with OT-551 reduces progression of the the area of geographic atrophy (GA) in subjects with GA associated with age-related macular degeneration (AMD).
A randomized, double-masked, multi-center, placebo-controlled, clinical trial of OT-551 (0.3% & 0.45%) in 137 subjects with GA was performed. The study eye was required to have ≥1 discrete areas of GA of ≥1.3 mm2 (0.5 disc area [DA]) and a total GA area of 1.3 to 17.8 mm2 (0.5 - 7.0 DA) that is within 3000 microns of the foveal center. Topical OT-551 was administered to only one qualifying eye 4X daily for up to 2 years. Visits were scheduled at screening, baseline (BL), and at 1, 3, 6, 9, 12, 15, 18, 21 & 24 months. Efficacy outcomes included changes from BL in total area of GA and best-corrected visual acuity (BCVA) score. Safety measures were assessed by complete ophthalmologic examination and review of ocular and systemic adverse events (AEs).
At BL, the mean (median) area of GA in study eyes from digital fluorescein angiograms was 6.17 (6.26) mm2 in the vehicle placebo group, 6.26 (5.72) mm2 in the OT-551 0.3% group, and 6.04 (5.11) mm2 in the OT-551 0.45% group. At month 18, mean (median) changes from BL of +3.55 (+3.08)mm2 in the placebo group, +3.01 (+2.91) mm2 in the OT-551 0.3% group, and +3.43 (+2.70) mm2 in the OT-551 0.45% group were observed. Mean (median) changes in BCVA at 18 months in study eyes were -4.9 (-3.0) letters in the placebo group, -8.9 (-6.0) letters in the OT-551 0.3% group, and -7.7 (-5.0) letters in the OT-551 0.45% group. The proportion of subjects losing ≥15 letters at month 18 was 16% in the placebo group, 20% in the OT-551 0.3% group and 21% in the OT-551 0.45% group. Most reported AEs were non-serious, mild in severity, and occurred at a low incidence (<5%). All serious AEs were non-ocular and none were related to the study drug.
While concentrations of OT-551 up to 0.45% appear to be safe when dosed 4X daily for up to two years, OT-551 does not appear to reduce the progression of the area of GA in subjects with AMD.
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