Table 1.
FDA Approved Photodynamic Therapies[49]
Brand name |
Formulation and light source |
Indication |
Dosing regimen |
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Visudyne® | Ingredients: 15 mg verteporfin plus lactose, egg phosphatidylglycerol, dimyristoyl phosphatidylcholine, ascorbyl palmitate and butylated hydroxytoluene | CNV treatment: Classic (“wet”) subfoveal choroidal neovascularization due to AMD | Photosensitizer dosage: 6 mg/m2 body surface area dose intravenously (diluted with 5% dextrose for 30 ml volume) |
Reconstitution: Each vial of Visudyne is mixed with 7 mL of sterile water to provide 7.5 mL containing 2 mg/mL verteporfin. The preparation must be used within 4 h after reconstituted | Classic subfoveal choroidal neovascularization secondary to pathological myopia | Light dosage: Exposure time of 83 seconds at a dose of 50 J/cm2 of neovascular lesion at a light intensity of 600 mW/cm2 | |
Approved light sources: Coherent Opal Photoactivator laser console and modified Coherent LaserLink adapter, Manufactured by Lumenis, Inc., Santa Clara, CA; Zeiss VISULAS 690s laser and VISULINK PDT/U adapter, Manufactured by Carl Zeiss Inc., Thornwood, NY. | Light application: Exposure to 689±3 nm wavelength (non-thermal red light) using diode laser 15 min after start of injection | ||
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Treatment spot size should be 1000 microns larger than the greatest linear dimension of the lesion on the retina to allow a 500 micron border. The maximum spot size used in clinical trials was 6400 microns. |
Photofrin® | Ingredients: 75 mg porfimer sodium as a freeze-dried cake or powder | Cancer treatments: Esophageal cancer | Photosensitizer dosage: 2 mg/kg body weight dose intravenously |
Reconstitution: Each vial of Photofrin is mixed with 31.8 ml of 5% dextrose or 0.9% sodium chloride resulting in a final concentration of 2.5 mg/kg porfimer sodium. The preparation must be protected from bright light and administered immediately | Non-small cell lung cancer | Light dosage: Exposure times of 12.5 min at a dose of 300 joules/cm of tumor length in esophageal cancer | |
Precancerous lesions in Barrett's Esophagus | Exposure time of 8.3 min at a dose of 200 joules/cm of tumor length in endobronchial cancer | ||
Approved light source: Cylindrical Optiguide− fiber optic diffusers are used to pass light through the operating channel of an endoscope/bronchoscope. | Light application: Exposure to 630 nm wavelength (non-thermal laser) after 40−50 h interval following injection | ||
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Optional 2nd laser application 96−120 h after injection Important to perform a debridement of residual tumor 2−3 days following each light administration |
Levulan ® | Ingredients: Plastic tube containing two sealed glass ampules; 1st ampule contains 1.5 ml of solution vehicle comprising alcohol USP (ethanol content = 48% v/v), water, laureth-4, isopropyl alcohol, and polyethylene glycol; 2nd ampule contains 354 mg of aminolevulinic acid HCl (Levulan Kerastick for Topical Solution) as a dry solid. | Actinic keratosis treatment: Minimally to moderately thick actinic keratosis (Grade 1 or 2) of the face and scalp | Photosensitizer dosage: Application of product with Levulan Kerastick |
Kerastick ® | Reconstitution: N/A Administered using Levulan Kerastick | Light dosage: Exposure time of 16.67 minutes at a dose of 10 J/cm2 | |
Approved light source: BLU-U Blue Light Photodynamic Therapy Illuminator | Light application: Exposure to 400−450 nm wavelength using blue light after 14−18 h interval following product application |