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terminology and guidelines for glaucoma ii - Kwaliteitskoepel

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3.3.1.5 - Category: PROSTAGLANDIN DERIVATIVES AND PROSTAMIDES 47,53-73<br />

Generics<br />

Tradenames<br />

Topical: Bimatoprost 0.03% Lumigan<br />

Latanoprost 0.005% Xalatan<br />

Travoprost 0.004% Travatan<br />

Unoprostone 0.12%, 0.15% Rescula<br />

Lumigan ® Xalatan ® Travatan ® Rescula ®<br />

Active ingredient* Bimatoprost Latanoprost Travoprost Unoprostone<br />

Category Prostamide Prostagl<strong>and</strong>in Prostagl<strong>and</strong>in Docosanoid<br />

Formulation 0.03% 0.005% 0.004% 0.12%, 0.15%<br />

Preservative BAC 0.05 mg/ml BAC 0.2 mg/ml BAC 0.15 mg/ml BAC 0.1 mg/ml<br />

0.005% 0.002% 0.015% 0.01%<br />

Dosage Once daily Once daily Once daily Twice daily<br />

*in alphabetic order<br />

Action<br />

For bimatoprost, latanoprost <strong>and</strong> travoprost the most evident action is the increase of the uveo-scleral outflow, reducing<br />

IOP 20% - 35%.<br />

The IOP lowering effect of unoprostone is up to 18% from baseline. Unoprostone 0.12% has been available in Japan<br />

since 1994.<br />

Pressure lowering effect: 53-61 Bimatoprost 7-8 mmHg (baseline 26 mmHg)<br />

Latanoprost 6-8 mmHg (baseline 24-25 mmHg)<br />

Travoprost 7-8 mmHg (baseline 25-27 mmHg)<br />

Unoprostone 3-4 mmHg (baseline 24-25 mmHg)<br />

Reduction of the intraocular pressure starts approximately 2-4 hours after the first administration with peak effect<br />

reached within approximately 8 to 12 hours. Maximum IOP lowering is often achieved 3 to 5 weeks from commencement<br />

of treatment<br />

Dosage <strong>and</strong> administration<br />

Bimatoprost 0.03%, latanoprost 0.005% or travoprost 0.004% solution: once daily, preferably in the evening.<br />

Unoprostone 0.12% <strong>and</strong> 0.15% BID.<br />

Indications<br />

Latanoprost has received European (EMEA) <strong>and</strong> FDA approval as first line drug <strong>for</strong> reducing intraocular pressure<br />

(IOP) in patients with open-angle <strong>glaucoma</strong> or ocular hypertension. A similar application as first-line treatment <strong>for</strong><br />

bimatoprost <strong>and</strong> travoprost have now also been made to the European regulatory agencies. The CPMP extended<br />

the indication <strong>for</strong> travoprost to first-line treatment in April 2003.<br />

There are only few published clinical trials with bimatoprost, latanoprost, travoprost <strong>and</strong> unoprostone in treating<br />

angle-closure <strong>glaucoma</strong>, inflammatory or neovascular <strong>glaucoma</strong>. Most of the large clinical trials of unoprostone are<br />

on the Japanese population.<br />

The prostagl<strong>and</strong>in analogues <strong>and</strong> prostamides (bimatoprost, latanoprost, travoprost <strong>and</strong> unoprostone) appear to be<br />

effective, well-tolerated agents <strong>for</strong> the reduction of intraocular pressure (IOP) in patients with primary open-angle<br />

<strong>glaucoma</strong> <strong>and</strong> ocular hypertension; most of the long-term data are published on latanoprost.<br />

This drug class offers potential as first choice drugs or an alternative <strong>for</strong> patients who do not achieve control the target<br />

IOP with another topical anti<strong>glaucoma</strong> agent or <strong>for</strong> those with a contraindication to initial therapy with beta-<br />

Ch. 3 - 18 EGS

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