Valeant Ophthalmics
Bridgewater, NJ – March 2, 2011 – Valeant Ophthalmics, a Division of Valeant Pharmaceuticals North America LLC, announced today that the Working Group on Preservatives Toxicity in Glaucoma Medications, an advisory panel of glaucoma treatment experts, was recently convened as an ongoing group to examine the issue of preservatives in glaucoma medications from an evidence-based perspective. The Working Group is sponsored by Valeant Ophthalmics.
At its first roundtable, the Working Group discussed the interface between ocular surface disease (OSD) and glaucoma, two chronic diseases, and reviewed the evidence regarding the effect of preservatives in glaucoma medications on the ocular surface.
“Early glaucoma is an asymptomatic disease and yet we are treating with medications that may induce side effects,” commented Robert Fechtner, M.D., Director, Glaucoma Division, Institute of Ophthalmology and Visual Sciences, New Jersey Medical School – UMDNJ. The group’s observations included the recommendation that the toxic effects glaucoma patients can experience as a result of preservatives in many glaucoma medications be recognized as a disease.
“The long-term view is to recognize preservative toxicity as a disease that may make glaucoma harder to treat,” said Paul Kaufman, M.D., University of Wisconsin. “What is required is a complete paradigm shift in how we look at surface toxicity. At the end of the day, preservative toxicity is going to translate into increased medical treatment of the side effects, discontinuation of topical drug therapy or perhaps even inflammation-induced failure of glaucoma surgery.”
Preservatives and Inflammation
Christophe Baudouin, M.D., Ph.D., University of Paris, summarized his early observations of inflammation in patients with glaucoma, a condition without an inherent inflammatory component.1
“I saw a relationship between inflammation and the preservatives of topical glaucoma medications,” related Dr. Baudouin. “First, I observed inflammation in a disease in which there is no reason to observe inflammation at the ocular surface. Second, the inflammation was not related to a specific compound or specific family of eyedrops but was a significant finding in patients treated for a long period of time or treated with several drugs, so it seemed logical to consider that there was something common to every treatment.” 1 Dr. Baudouin also noted the difficulty of recognizing preservative toxicity.
“A toxic reaction accumulating over time in a patient treated with two, three, four drugs is something that is not caught by evidence-based medicine because clinical trials are focusing on a specific population with a specific drug for a specific duration,” explained Dr. Baudouin.2
Effect on Vision
“Blurred vision is an important issue in ocular surface disease,” observed Robert J. Noecker, M.D., Ophthalmic Consultants of Connecticut. “Fluctuating and blurred vision is the number one problem with ocular surface disease patients, not the red eye complaint. Patients come to us for their vision a lot more often than for red, scratchy eyes.” Stephen C. Pflugfelder, M.D., Baylor College of Medicine explained how preservatives affect vision.
“It’s been recognized for decades that preservatives are detergents,” detailed Dr. Pflugfelder. “They break the tight junctions in the apical epithelial cells in the cornea and probably the conjunctiva also. They may have some cytotoxic activity themselves and in certain concentrations will cause apoptosis or programmed cell death or necrosis.1 So, from multiple mechanisms, preservatives can impact on the barrier function in the cornea. And as the cells start to be lost from the apical cornea, then the ability of the cornea to hold the tear film diminishes. The tear film becomes more unstable, and then patients complain of blurred and fluctuating vision and reduction in their best corrected visual acuity, in some cases to almost functional blindness.”
About the Working Group on Preservatives Toxicity
The roundtable of the Working Group on Preservatives Toxicity in Glaucoma Medications was convened by Ethis Communications, Inc., publisher of The Ocular Surface, and Valeant Ophthalmics, a Division of Valeant Pharmaceuticals North America, LLC. Working Group members were compensated for their time in compliance with government and industry guidelines. The Working Group was chaired by Stephen Obstbaum, M.D., NYU Langone Medical Center. Members attending the roundtable were:
- Christophe Baudouin, M.D., Ph.D., Quinze-Vingts National Hospital, University of Paris
- Paul Kaufman, M.D., University of Wisconsin
- Stephen C. Pflugfelder, M.D., Baylor College of Medicine
- Robert J. Noecker, M.D., Ophthalmic Consultants of Connecticut
- Robert Fechtner, M.D., Director, Glaucoma Division, Institute of Ophthalmology and Visual Sciences, New Jersey Medical School – UMDNJ
- Gail Schwartz, M.D., Glaucoma Consultants, Baltimore; Assistant Professor, Wilmer Eye Institute
- Don Budenz, M.D., M.P.H., Chair of Ophthalmology, University of North Carolina at Chapel Hill
1. Baudouin C et al. Preservatives in eyedrops: the good, the bad and the ugly. Prog Retin Eye Res. 2010 Jul;29(4):312-34.
2. Eamon W. Leung, MD, Felipe A. Medeiros, MD, PhD, and Robert N. Weinreb, MD. Prevalence of Ocular Surface Disease in Glaucoma Patients. J Glaucoma 2008;17:350–355
Ed Stevens Chase Communications for Valeant Ophthalmics
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