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Five-year, Multicenter Safety Study of Fixed-combination Latanoprost/Timolol (Xalacom) for Open-angle Glaucoma and Ocular Hypertension

Alm, Albert MD*; Grunden, John W. PharmD; Kwok, Kenneth K. MS

doi: 10.1097/IJG.0b013e3181e08121
Original Studies

Purpose To evaluate the safety of fixed-combination latanoprost/timolol (Xalacom) in patients requiring additional intraocular pressure (IOP) reduction over 5 years.

Methods This phase 3b, open-label, multicenter study included prostaglandin-naive participants with open-angle glaucoma or ocular hypertension insufficiently responsive to β-blockers and requiring additional IOP reduction. Participants were evaluated at eleven 6-month visits. A masked assessor evaluated iris/eyelash changes at baseline and 12, 36, and 60 months. Increased iris pigmentation incidence was compared with a historic control from a similarly designed study evaluating latanoprost. Ocular and systemic adverse events were recorded.

Results Among 828/974 treated participants with assessable iris photographs, 233 (28.1%) developed increased iris pigmentation versus 127/380 (33.4%) in the historic controls. Participants with mixed eye colors exhibited greater susceptibility to overall increased iris pigmentation (85.8% in both studies). In this study, most participants (80.3%) with increased iris pigmentation developed only a weak increase. Eyelash changes were seen in 58.1% of participants and darkening of the eyelids in 5-6%; 14.1% experienced a serious adverse event. Adverse events resulted in treatment withdrawal in 133 (13.7%) participants. Most were nonserious ocular adverse events, about half of them ocular irritation. Only 3 of 13 serious systemic adverse events were considered to be drug related by the investigator. Mean IOP reductions were stable over 5 years.

Conclusions After 5 years, more than 70% of participants treated with fixed-combination latanoprost/timolol had no increased iris pigmentation. The fixed combination is safe and well tolerated for long-term treatment in patients with open-angle glaucoma or ocular hypertension.

*University Hospital Uppsala, Uppsala, Sweden

Pfizer Inc, New York, New York

This research was supported by Pfizer Inc, New York, New York.

Dr Grunden and Mr. Kwok are employees of Pfizer Inc.

The results of this study were presented in part at the Annual Meeting of the Association for Research in Vision and Ophthalmology, April 27 to May 1, 2008, in Ft. Lauderdale, Florida, USA; at the meeting of the European Glaucoma Society, June 1 to 6, 2008, in Berlin, Germany; and at the World Ophthalmology Congress, June 29 to July 2, 2008, in Hong Kong, China.

Editorial support, including contributing to the first draft of the manuscript, revising the paper based on researcher feedback, and styling the paper for journal submission, was provided by Jane G. Murphy, PhD, of Zola Associates and was funded by Pfizer Inc.

Reprints: Albert Alm, MD, Department of Neuroscience, Ophthalmology, University Hospital, SE75185, Uppsala, Sweden (e-mail: albert.alm@akademiska.se).

Received October 28, 2009

Accepted March 28, 2010

© 2011 Lippincott Williams & Wilkins, Inc.