Source: Haematologica  |  Posted 6 years ago

Important Medical Need Answered by New Format

MONTREAL, CANADA -- November 3, 2005 -- Canadians suffering from glaucoma and their treating physicians can now turn to a new preservative-free treatment when indicated.

Merck Frosst Canada Ltd. has received regulatory approval for Cosopt? (dorzolamide hydrochloride/timolol maleate) in a preservative free-unit dose. The new product formulation will be available by prescription from the beginning of November.

Preservative-free dorzolamide hydrochloride/timolol maleate answers an important medical need. All other glaucoma treatments currently approved in Canada contain one of three different preservatives. The most common preservative in glaucoma treatments, benzalkonium or BAK, has been associated with allergic reactions and side effects such as irritation and inflammation of the eyes in some patients.[^]1[]

It is estimated that as many as six per cent of glaucoma patients are allergic to BAK.[^]1[] Currently, the only other preservative-free medication is Timoptol UD. However, it is only accessible in Canada through Health Canada's Special Access Program.

Dorzolamide hydrochloride/timolol maleate is indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or glaucoma. Dorzolamide hydrochloride/timolol maleate contains two active ingredients that have been demonstrated to reduce pressure inside the eye caused by open angle glaucoma or other eye diseases such as ocular hypertension. It works by decreasing the amount of fluid within the eye. Lowering high pressure inside the eye helps to prevent blindness.[^]2[]

"The introduction of Cosopt? in a preservative-free format provides a much needed alternative for glaucoma patients. Up until now, in preservative-sensitive cases, the only other approved options were laser therapy or surgery," said Dr. Shawn Cohen, Assistant Professor of Ophthalmology at McGill University. "This new option may allow us to defer or even avoid laser or surgery in preservative-sensitive cases."

Dorzolamide hydrochloride/timolol maleate preservative-free unit dose will be packaged in cartons of 60 unit doses and each unit dose will contain 0.2ml.

About glaucoma
It is estimated that glaucoma affects 1 in 100 Canadians over 40.[^]3[] In 2002, it accounted for more than 6% of the Canadian National Institute for the Blind registrations.[^]4[] Glaucoma is an eye disease caused by increased pressure within the eye. Open-angle glaucoma, the most common form of the disease, causes a gradual loss of nerve function. If left untreated, glaucoma can lead to a complete loss of peripheral vision.

Since open-angle glaucoma does not cause apparent symptoms, it often goes undetected until irreversible damage has occurred to a patient's vision. The best way to avoid permanent damage to the eye is to diagnose the disease early, through regular eye exams by an eye care professional.

While it is more common among people over the age of 40, glaucoma can affect people at any age.[^]5[] Other factors that increase a person's risk of having glaucoma include having a close relative with the disease, being nearsighted, and having poor health (e.g. early heart attack or stroke).[^]3[]

Cosopt? is a registered trademark of Merck & Co., Inc.

REFERENCES:
1. Van Beek LM et al. Incidence of ocular side effects of topical ? blockers in the Netherlands. Br J Ophthalmol. 2000;84:856-859.
2. Cosopt product monograph.
3. http://www.cnib.ca/eng/eye_con/glaucoma.htm, accessed October 6, 2005.
4. CNIB Client Statistics 2002. Available at http://www.cnib.ca/eng/publications/pamphlets/stats/CNIB_Client_Stats_02..., accessed October 6, 2005.
5. http://www.eyesite.ca/english/public-information/eye-conditions/pdfs/Gla..., accessed October 11, 2005.

SOURCE: Merck Frosst