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Study Demonstrates Benefits of Combination Treatment for Glaucoma

Disease Deteriorates Peripheral Vision Affects at Least 300,000 Canadians[i]

MONTREAL, CANADA -- May 11, 2006 -- Preliminary results from the Canadian EXACCT study (Evaluation of latanoprost (Xalatan) and CosoptŪ in Combination or CosoptŪ in monoTherapy) were presented to close to 10,000 people attending the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Fort Lauderdale, Florida.

Results demonstrate that 92.6% of patients enrolled in the study who were previously not responding to or were uncontrolled with latanoprost, achieved clinically significant additional reduction in intraocular pressure (IOP) when treated with CosoptŪ (dorzolamide hydrochloride/timolol maleate) alone or when CosoptŪ was added to latanoprost, allowing patients to reach their therapeutic goals.

The average additional reduction of IOP in the patient group receiving both latanoprost and CosoptŪ was 28.3% (15.78 mmHg vs. 22.34 mmHg) from the latanoprost baseline. The group of patients who were previously not responding to latanoprost and were treated with CosoptŪ alone achieved an average reduction of 24.4% in IOP (17.29 mmHg vs. 23.14 mmHg) from the latanoprost baseline.

"Results from this study bring a different perspective on the use of CosoptŪ. We now have clinical evidence that CosoptŪ helps patients who are not controlled to target and those who are not responding to latanoprost achieve their target intraocular pressure and bring their pressure under control," said ophthalmologist Dr. Mark Lesk, EXACCT study co-author and vision health researcher with the Guy-Bernier Research Centre at Montreal's Maisonneuve-Rosemont Hospital, University of Montreal.

The EXACCT study is a multicenter, open-label, 12-week prospective cohort study. A total of 343 patients were recruited by 33 Canadian physicians, making it the largest study to measure the effects of adding CosoptŪ to latanoprost. Preliminary results presented yesterday relate to 243 participants who completed the study at the time of the analysis.

· Mean age of participants was 68;
· 56% were women;
· 196 patients with either open-angle glaucoma or ocular hypertension whose IOP remained uncontrolled after a four week treatment with latanoprost were recruited and CosoptŪ was added to latanoprost;
· 47 patients who did not respond to latanoprost therapy (<15% IOP reduction) were switched to CosoptŪ;
· No serious adverse events occurred in patients using CosoptŪ. The overall treatment strategy was generally well tolerated by patients. The majority (77%) of adverse events were mild in nature and did not require discontinuation of study treatment.

About glaucoma
It is estimated that glaucoma affects 1 in 100 Canadians over 40.[ii] In 2002, it accounted for more than 6% of the Canadian National Institute for the Blind registrations.[iii] 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 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.[iv] Other factors that increase a person's risk of having glaucoma include having a close relative with the disease, African origins, being nearsighted, and having poor health (e.g. early heart attack or stroke).

About CosoptŪ
CosoptŪ is indicated for the treatment of elevated intraocular pressure in patients with ocular hypertension or glaucoma. CosoptŪ contains two active ingredients, dorzolamide hydrochloride and timolol maleate, 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.

CosoptŪ is available in 5 mL and 10 mL OCUMETER PLUSŪ dispensers as well as in a preservative-free ophthalmic solution packaged in 60 x 0.2 mL individual fill volume unit dose pipettes.


REFERENCES:
[i] Canadian National Institute for the Blind media release, April 5, 2002. Available at: http://www.cnib.ca/eng/media-centre/stories/natcol_report.htm, referenced April 20, 2006.
[ii] Canadian Ophthalmological Society glaucoma overview. Available at: http://www.eyesite.ca/english/public-information/eye-conditions/pdfs/Glaucoma.pdf, referenced April 20, 2006.
[iii] Canadian National Institute for the Blind client statistics 2002. Available at: http://www.cnib.ca/eng/publications/pamphlets/stats/CNIB_Client_Stats_02_Eng.pdf, referenced April 21, 2006.
[iv] Canadian Ophthalmological Society glaucoma overview. Available at: http://www.eyesite.ca/english/public-information/eye-conditions/pdfs/Glaucoma.pdf, referenced April 20, 2006.


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SOURCE: Merck & Co., Inc.

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