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J. W. Grunden, A. Alm; 5-Year, Multicenter Safety Study of Fixed-Combination Latanoprost/Timolol (Xalacom) for Open-Angle Glaucoma (OAG) and Ocular Hypertension (OH). Invest. Ophthalmol. Vis. Sci. 2008;49(13):1222. doi: https://doi.org/.
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To study the safety of fixed-combination latanoprost/timolol (FCLT) in patients requiring additional intraocular pressure (IOP) reduction over 5 years.
This was an open-label, phase 3b, multicenter safety study of FCLT in subjects with OAG/OH insufficiently responsive to β-blockers and requiring additional IOP reduction. Subjects ≥18 years age with OAG/OH and prostaglandin naive were evaluated at eleven 6-monthly visits. Safety endpoints were incidence of increased iris pigmentation (IIP) in at least 1 eye, changes in periorbital skin or eyelashes, and occurrence of ocular/periorbital adverse events (AEs) and of serious AEs (SAEs). IIP and changes in eyelashes were assessed by a masked reader from iris and en face photographs (IRIS system) taken at baseline and at years 1, 3, and 5 and by subjects and investigators at each visit. Incidence of IIP was compared to historical controls from a similarly designed study (Alm A, et al. Arch Ophthalmol 2004;122:957-65).
Following are interim 3-year data. Of 974 subjects with ≥1 drop of FCLT (analysis population), 157 (16.1%) developed IIP, 453 (46.5%) had no IIP (NIIP), 364 (37.4%) had no IRIS photo data; 663 (68.1%) completed 3 years of treatment. Subjects with IIP were highly likely to have mixed eye color (85.3%). In the IIP and NIIP groups, respectively, similar percentages of subjects had ≥1 AE, discontinued due to an AE, and had ≥1 SAE (55.4% vs 53.2%; 1.3% vs 0.9%; 6.4% vs 7.1%). FCLT-related SAEs were rare. No deaths were reported in the IIP or NIIP groups. The maximum grade of IIP generally was classified as "weak" and was stable from months 12 to 36. The IRIS system judged a higher percentage of subjects developed IIP than investigators or subjects (16.1% vs 10.1% vs 4.8%). Mean IOP reduction was stable over 3 years (3-year mean: -4.6±3.5 mmHg). After 36 months, 157/610 (25.7%) evaluable subjects developed IIP compared to 127/380 (33.4%) historical controls; the difference could be due to differences in study procedures. Five-year data will be reported.
FCLT is safe and well tolerated for long-term OAG/OH treatment.
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