 |
 |
Visudyne®
(verteporfin for injection)
|
|
|
Visudyne is the first drug therapy approved by the Food and Drug Administration for treatment of age-related macular degeneration (AMD) in patients with predominantly classic subfoveal choroidal neovascularization. Visudyne is also indicated for treatment of pathologic myopia or presumed ocular histoplasmosis.
When activated by light, Visudyne causes local damage to the neovascular endothelium in the macula, resulting in vessel occlusion. Visudyne photodynamic therapy slows or stops progression of wet age-related macular degeneration, thereby reducing the risk of vision loss.
Clinical Studies in Age-Related Macular Degeneration
Two adequate, well-controlled, double-masked, placebo-controlled, randomized studies were conducted in 609 patients (402 Visudyne, 207 placebo) who had classic-containing subfoveal choroidal neovascularization secondary to age-related macular degeneration. Retreatment was allowed every 3 months if fluorescein angiograms demonstrated any recurrence or persistence of leakage.
For the primary efficacy end point (defined as the percentage of patients who lost less than 3 lines of visual acuity), the between-group treatment difference was approximately 28% at both Month 12 (67% for Visudyne compared with 40% for placebo) and Month 24 (59% for Visudyne compared with 31% for placebo). Severe vision loss (defined as ≥ 6 lines of visual acuity from baseline) affected 12% of Visudyne-treated patients compared with 34% of placebo-treated patients at Month 12 and 15% compared with 36%, respectively, at Month 24.
Back to Top
Administration of Visudyne Therapy
Visudyne photodynamic therapy is a two-step process requiring administration of both drug and light.
- Visudyne (6 mg/m²) is injected intravenously into the arm for 10 minutes. Visudyne appears to accumulate preferentially in neovasculature, including choroidal neovasculature. The drug may also be present in the retina.
- Visudyne is activated by shining a pre-calculated dose of light at a particular (wavelength 689 nm) by a low-energy laser into the affected area of the retina for 83 seconds. In the treatment of choroidal neovascularization, the recommended light dose is 50 J/cm² administered at an intensity of 600 mW/cm². Activated Visudyne causes conversion of normal oxygen found in tissue to a highly energized form called "singlet oxygen." The singlet oxygen, in turn, causes cell death by disrupting normal cellular functions.
Visudyne photodynamic therapy is performed as an outpatient procedure. If CNV leakage is detected on the fluorescein angiograms, therapy should be repeated at three months.
For more Information
For more information, please visit the Visudyne Web site at www.visudyne.com.
Full Prescribing Information
Back to Top
|
|
|
| |
 |
|
| EYE DISEASES & DISORDERS | | | Facts on specific eye diseases | | | Read More > | |
|
|
|
