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. Author manuscript; available in PMC: 2009 Feb 1.
Published in final edited form as: Drug Discov Today. 2008 Feb 1;13(3-4):124–134. doi: 10.1016/j.drudis.2007.12.005

Table 1.

FDA Approved Photodynamic Therapies[49]

Brand name
Formulation and light source
Indication
Dosing regimen
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



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



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
HHS Vulnerability Disclosure