Visudyne - Drug Information | Physicians Office Resource

Overview

Verteporfin, a synthetic benzoporphyrin derivative, is a cytotoxic photosensitizing agent that is activated by low-intensity nonheat-generating laser light at a wavelength corresponding to the absorption peak of verteporfin (i.e., 689 nm).

Verteporfin, a synthetic benzoporphyrin derivative, is a cytotoxic photosensitizing agent that is activated by low-intensity nonheat-generating laser light at a wavelength corresponding to the absorption peak of verteporfin (i.e., 689 nm). The drug is used as a component of photodynamic therapy in which a photosensitive compound is activated by light in the presence of oxygen, resulting in a physiochemical event that can be used to selectively damage pathologic structures. Activation of verteporfin leads to generation of highly-reactive, short-lived singlet oxygen and reactive oxygen intermediates that cause local cytotoxic effects.

When verteporfin is used in the management of subfoveal choroidal neovascularization, light activation of the drug in the eye results in local damage to the neovascular endothelial cells, which leads to temporary occlusion of choroidal neovasculature.

The specificity and preferential uptake of verteporfin by cells expressing high levels of low-density lipoprotein receptors (e.g., neovascular endothelial cells, tumor cells) have been enhanced by use of a liposomal-based formulation of the drug that is transported by low-density lipoproteins (LDLs) in plasma. While verteporfin apparently accumulates preferentially in neovasculature, including choroidal neovasculature, evidence from animal models indicates that the drug also is distributed to the retina. Therefore, collateral damage to retinal structures (e.g., retinal pigmented epithelium, outer nuclear retinal layer) may occur following photoactivation of verteporfin.

Verteporfin is metabolized to a small extent by liver and plasma esterases to a diacid metabolite that exhibits pharmacologic activity similar to that of verteporfin. The drug apparently is not metabolized by NADPH-dependent liver enzymes (including the cytochrome P-450 (CYP) enzymes). Verteporfin is excreted principally as unchanged drug in feces with only small amounts of the drug (<0.01% of an administered dose) recovered in urine.

USES: Verteporfin is used along with laser light treatment to treat certain serious eye conditions (such as macular degeneration, pathologic myopia, ocular histoplasmosis). It is used to help prevent decreased vision and blindness. After you have received the injection of verteporfin, your doctor will use laser light treatment on the affected eye(s).

The laser light will change the drug to a form that works by damaging only those cells that cause the serious eye problem.

Generic name: verteporfin
Pronunciation: (VER-te-POR-fin)

Reference product & biosimilars

No reference, biosimilar or interchangeable associated with this drug.

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Indications

The following indications are listed for Visudyne:

Choroidal Neovascularization
Neovascular Age-Related Macular Degeneration
Ocular Histoplasmosis
Pathologic Myopia

Also known as: Armd With Choroidal Neovascularization, Choroid Neovascularization, Darling's Disease Of The Eye, Ophthalmic Histoplasmosis, Pathologic Nearsightedness, Pathologic Shortsightedness, Senile Macular Degeneration With Subretinal Neovascularization, Senile Macular Retinal Degeneration.

Dosing

The usual dose of verteporfin in the treatment of subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia, or presumed ocular histoplasmosis is 6 mg/m2. The recommended light dose is 50 J/cm2 of neovascular lesion administered at an intensity of 600 mW/cm2 over 83 seconds. Light dose, light intensity, ophthalmic lens magnification factor, and zoom lens setting are important parameters for the appropriate delivery of light to the predetermined treatment spot. The greatest linear dimension (GLD) of the lesion, including all classic and occult choroidal neovascularization, blood and/or blocked fluorescence, and any serous detachments of the retinal pigment epithelium, is estimated by fluorescein angiograph and color fundus photography and is corrected for the magnification of the fundus camera to obtain the GLD of the lesion on the retina. The treatment spot size should be 1000 mcm larger than the GLD of the lesion on the retina to allow a 500-mcm border and ensure full coverage of the lesion. In clinical studies the maximum spot size used was 6400 mcm. The nasal edge of the treatment spot must be positioned as least 200 mcm from the temporal edge of the optic disc, even if this will result in lack of exposure of choroidal neovascularization within 200 mcm of the optic nerve.

Photodynamic therapy with verteporfin may be repeated every 3 months in patients with choroidal neovascular leakage detected on fluorescein angiography. Results of clinical studies in patients with subfoveal choroidal neovascularization due to age-related macular degeneration showed that the average number of treatments decreased from 3.4 during the first year to 2.1 during the second year (total of 5.4 treatments over the 24-month period). Safety and efficacy of photodynamic therapy with verteporfin for longer than 2 years have not been established to date.

Drug interactions

There is no enhanced messaging for this drug.

Contraindications

Porphyria.

Known hypersensitivity to verteporfin or any ingredient in the formulation.

Adverse reactions

Injection site reactions and visual disturbances were the most frequently reported adverse effects among those reported in 1% or more of patients receiving verteporfin. In clinical studies in patients with subfoveal choroidal neovascularization due to age-related macular degeneration, injection site reactions (e.g., extravasation, rash) were reported in 15.9 or 5.8% of patients receiving verteporfin or placebo, respectively; cataracts were reported in up to 14.9% of verteporfin-treated patients and 15% of placebo-treated patients. Blepharitis; conjunctivitis/conjunctival injection; dry eyes; ocular itching; severe vision loss with or without subretinal or vitreous hemorrhage; back pain during infusion; asthenia; fever; flu-like syndrome; atrial fibrillation; hypertension; peripheral vascular disorder; varicose veins; eczema; constipation; GI cancers; nausea; anemia; leukocyte count increase/decrease; increased liver function test results; albuminuria; serum creatinine increase; arthralgia; arthrosis; myasthenia; hypesthesia; sleep disorder; vertigo; cough; pharyngitis; pneumonia; hearing decrease; diplopia; lacrimation disorder; and prostatic disorder occurred in 1-10% of verteporfin-treated patients.

Retinal detachment (nonrhegmatogenous), retinal or choroidal vessel nonperfusion, chest pain and other musculoskeletal pain during infusion, syncope, and vasovagal reactions have occurred in patients receiving verteporfin.

Precautions

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ICD codes

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Formulary status

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Visudyne (verteporfin)