Valeant Ophthalmics
Bridgewater, NJ – March 20, 2012 – 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, recently issued recommendations regarding how to avoid the potentially toxic effects of the preservatives used in many glaucoma medications. The Working Group is sponsored by Valeant Ophthalmics.
The Working Group discussed the tendency they observed for physicians to deal with ocular surface disease symptoms by adding a steroid or other medication rather than removing the offending agents. The Working Group members disagreed with this “additive” approach and offered “subtractive” alternatives.
“The first thing we do is take them off the multiple preserved medications,” explained Stephen C. Pflugfelder, M.D., Baylor College of Medicine. “My clinic is full of patients that have toxicity, redness or severe lid margin problems. It’s a vicious cycle because the preservative destabilizes the tear film and the whole process just escalates.1 I found that unless I take them off the offending agent I’m never going to get to the bottom of the problem.”
Reviewing first-line glaucoma therapy options, the Working Group members pointed out that prostaglandins were the first choice of most ophthalmologists because of their dosing, efficacy and safety. They recommended a beta blocker such as timolol for additive therapy when required except in cardiovascular and pulmonary patients where contraindicated.* Timolol is available in the U.S. in a preservative free formulation as TIMOPTIC® in OCUDOSE® (TIMOLOL MALEATE 0.5% OPHTHALMIC SOLUTION). TIMOPTIC® in OCUDOSE® is a topical beta blocker, but is absorbed systemically; therefore the same adverse reactions and contraindications are found with topical administration. (See Indications and Important Safety Information below).2
“If someone is not at their treatment goal, adding timolol once a day can often times get them to the goal,” reported Don Budenz, M.D., M.P.H., Chair of Ophthalmology, University of North Carolina at Chapel Hill. “You can use timolol once a day and get a good effect with similarly low side effects.”2
Christophe Baudouin, M.D., Ph.D., University of Paris, reported similar success with the use of beta blockers, reiterated their long clinical history and reported that in Europe, preservative-free beta blocker formulations available since 1997 are experiencing considerable growth. Robert J. Noecker, M.D., Ophthalmic Consultants of Connecticut, remarked that in the U.S., in contrast, awareness of the benefits of beta blockers and the availability of preservative-free formulations was low among ophthalmologists.
Dr. Baudouin provided an overview of previous studies that documented the positive impact of switching to a preservative-free medication, without a compromise in efficacy.3
Indications
Preservative-free TIMOPTIC® in OCUDOSE® (TIMOLOL MALEATE 0.5% OPHTHALMIC SOLUTION) is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. Preservative-free TIMOPTIC® in OCUDOSE® may be used when a patient is sensitive to the preservative in TIMOPTIC® (timolol maleate ophthalmic solution), benzalkonium chloride, or when use of a preservative-free topical medication is advisable.
Important Safety Information
Timoptic is contraindicated in patients with: bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease; sinus bradycardia; second or third degree atrioventricular block; overt cardiac failure; cardiogenic shock; hypersensitivity to any component of this product.
This drug is absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. Severe respiratory or cardiac reactions, including death, have been reported following systemic or ophthalmic administration of timolol maleate. TIMOPTIC® should be used with caution in patients with cerebrovascular insufficiency.
The most frequently reported adverse experiences have been burning and stinging upon instillation.
Please see accompanying TIMOPTIC® in OCUDOSE® full Prescribing Information.
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. de Jong C, Stolwijk T, Kuppens E, de Keizer R, van Best J. Topical timolol with and without benzalkonium chloride: epithelial permeability and autofluorescence of the cornea
in glaucoma. Arch Clin Exp Ophthalmol 1994, 232:221-224
2. TIMOPTIC® in OCUDOSE® Full Prescribing Information
3. N. JAENEN, C. BAUDOUIN, P. POULIQUEN, G. MANNI, A. FIGUEIREDO, T. ZEYEN. Ocular symptoms and signs with preserved and preservative-free glaucoma medications. European Journal of Ophthalmology / Vol. 17 no. 3, 2007 / pp. 341-349.
Attachment: TIMOPTIC® in OCUDOSE® full Prescribing Information
Ed Stevens
Chase Communications for Valeant Ophthalmics
727-327-3396
[email protected]