Valeant Ophthalmics
Yet Fewer Than Half Apply Awareness in Treatment Decisions
Bridgewater, NJ – May 7, 2012 – Valeant Ophthalmics, a Division of Valeant Pharmaceuticals North America, LLC, today announced results of a recent survey of ophthalmologists conducted for the Working Group on Preservative Toxicity in Glaucoma Medications. The Working Group, an advisory panel of glaucoma treatment experts convened as an ongoing group to examine the issue of preservatives in glaucoma medications from an evidence-based perspective, is sponsored by Valeant Ophthalmics.
The survey examined awareness, opinions and behaviors regarding preservatives in glaucoma medications and was conducted among 117 ophthalmologists.1 The survey revealed that while some progress has been made in ophthalmologists’ awareness of preservative toxicity, application in patient treatment has lagged behind awareness.
Ocular Surface Disease and Preservatives
Ocular surface disease (OSD) includes a group of disorders that affect various components of the ocular surface, often resulting in dysfunction of the ocular tear film or the integrity of the ocular surface. Virtually all respondents (97%) felt that underlying OSD in patients with glaucoma may be exacerbated by the use of preserved glaucoma medications, and 76% reported preservatives in glaucoma medications were a significant cause of the OSD they see in glaucoma patients.
However, only 20% reported that the presence of preservatives in glaucoma medications had a high impact on their glaucoma prescribing decisions. Although low, this proportion is higher than the 13% who reported preservatives had a high impact in a similar survey in 2009.2 Ophthalmologists were somewhat split on whether there was sufficient evidence on the positive or negative impact of preservatives – 57% felt there was sufficient evidence.
Lowering IOP as Primary Focus
The main concern of ophthalmologists in glaucoma treatment is still effectiveness in lowering intraocular pressure (IOP), ranked as the number one factor in their decisions about glaucoma therapy, while preservative toxicity was among the lowest ranked factors.
“In spite of the strong evidence of the toxic effect of preservatives in glaucoma medications on the ocular surface, many ophthalmologists are still not convinced,” observed Stephen Obstbaum, M.D., NYU Langone Medical Center. “Lowering IOP remains the single-minded goal of many glaucoma treaters, while preservative toxicity may actually be making the patient’s glaucoma more difficult to treat.”
Patients at Risk
The survey respondents were aware that patients at high risk for toxic effects of the preservatives in their glaucoma medications included patients with moderate to severe signs of OSD (74%) and patients on three or more glaucoma medications (69%). Virtually all (96%) were aware that the additive effect of preservatives in patients taking multiple medications increases the risk for preservative toxicity and ocular surface disease. However, only half (53%) identified patients with dry eye symptoms – often indicative of OSD -- as high risk for preservative toxicity.
While nearly all recognized the benefit of avoiding preservative toxicity – with 91% agreeing that “using a preservative-free glaucoma medication can prevent or reduce ocular surface disease in susceptible patients” -- only 47% reported they switch patients with OSD to non-preserved glaucoma medications. Among those who did not switch patients to non-preserved medications, most (68%) gave as a reason that if the patient’s IOP is controlled, they are reluctant to change medications.
Preservative-Free Beta-Blockers
The vast majority (81%) reported being aware of preservative-free beta-blockers, a considerably higher percentage than in 2009, when 53% reported being aware of them. When asked what they would prescribe as second-line therapy for a glaucoma patient on a preservative-free prostaglandin whose IOP was not adequately controlled, half (51%) reported they would prescribe a preservative-free beta blocker; only 28% would prescribe a preserved beta blocker.
A beta blocker such as timolol can be prescribed for additive therapy when required except in cardiovascular and pulmonary patients, where it is contraindicated.* Timolol is available in the U.S. in a preservative-free formulation as TIMOPTIC® (timolol maleate 0.5% ophthalmic solution) in OCUDOSE® (dispenser).
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.
Survey Methodology
The survey was conducted by ADVANSTAR Healthcare Group for the Working Group on Preservative Toxicity, funded by Valeant Ophthalmics. An invitation and link for the online survey were sent to Ophthalmology Times subscribers, requesting their participation in a survey regarding glaucoma medications. While neither the Working Group nor the specific focus on preservative toxicity was identified in the invitation, no attempt was made to ascertain whether those choosing to respond represent a self-selected bias that could have affected the results.
Respondents were screened based on number of glaucoma patients treated; only respondents who treated at least 20 glaucoma patients per month were selected to complete the survey. The survey was closed after 117 qualifying ophthalmologists responded and the results were tabulated by ADVANSTAR. Given the relatively small sample for the survey, comparisons between sub-groups may not represent statistically significant differences.
About the Working Group on Preservative Toxicity
The Working Group on Preservative 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 examines data regarding the issue of preservatives in glaucoma medications and discusses evidence-based clinical management and does not endorse any particular products. The Working Group was chaired by Stephen Obstbaum, M.D., NYU Langone Medical Center. Members include:
Christophe Baudouin, M.D., Ph.D., Quinze-Vingts National Hospital, University of Paris
Paul Kaufman, M.D., University of Wisconsin-Madison
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
- Preservative Toxicity Survey of Ophthalmologists, The Working Group on Preservative Toxicity, survey conducted by ADVANSTAR Healthcare Group, March 2012.
- Preservative Toxicity Survey of Ophthalmologists, survey conducted by ADVANSTAR Healthcare Group, March 2009.
CONTACT:
Ed Stevens
Chase Communications
727-327-3396
[email protected]