Verteporfin

VISUDYNE (verteporfin for injection) therapy is a two-stage process requiring administration of both verteporfin for injection and nonthermal red light. Verteporfin is transported in the plasma primarily by lipoproteins.

• VISUDYNE ® (verteporfin for injection) therapy is indicated for the treatment of patients with predominantly classic subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD), pathologic myopia or presumed ocular histoplasmosis. There is insufficient evidence to indicate VISUDYNE for the treatment of predominantly occult subfoveal CNV.

• VISUDYNE (verteporfin for injection) is contraindicated for patients with porphyria or a known hypersensitivity to any component of this preparation [see Adverse Reactions ( 6 )] . VISUDYNE (verteporfin for injection) is contraindicated for patients with porphyria or a known hypersensitivity to any component of this preparation.contraindicated

• Recommended Dose : 6 mg/m 2 body surface area. ( 2.2 ) • Reconstitution : Reconstitute each vial of VISUDYNE with 7 mL of Sterile Water for Injection to provide 7.5 mL containing 2 mg/mL of verteporfin. Reconstituted VISUDYNE must be protected from light and used within 4 hours. ( 2.3 ) • Dilution : Dilute desired dose of reconstituted VISUDYNE with 5% Dextrose for Injection to a total infusion volume of 30 mL. ( 2.3 ) • Infusion : Administer intravenously over 10 minutes at a rate of 3 mL/minute, using an appropriate syringe pump and in-line filter. ( 2.3 ) • Light Administration : The recommended light dose is 50 J/cm 2 of neovascular lesion administered at an intensity of 600 mW/cm 2 . The wavelength of the laser light should be 689±3 nm. This light dose is administered over 83 seconds, starting 15 minutes after the start of the VISUDYNE infusion. ( 2.4 ) 2.1 Important Administration Instructions A course of VISUDYNE (verteporfin for injection) therapy is a two-step process requiring administration of both drug and light. • The first step is the administration of VISUDYNE. • The second step is the activation of VISUDYNE with light from a nonthermal diode laser. The physician should re-evaluate the patient 3 months after treatment and if choroidal neovascular leakage is detected on fluorescein angiography, therapy may be repeated. Lesion Size Determination The greatest linear dimension (GLD) of the lesion should be estimated by fluorescein angiography and color fundus photography.

• Extravasation : If extravasation occurs, the infusion should be stopped immediately. The extravasation area must be thoroughly protected from direct light until swelling and discoloration have faded in order to prevent the occurrence of local burn. ( 5.1 ) • Exposure to Sun or Direct Light : Following injection with VISUDYNE (verteporfin for injection), care should be taken to avoid exposure of skin or eyes to direct sunlight or bright indoor light for 5 days. ( 5.2 ) • Anaphylactic Reactions : Immediately discontinue administration of VISUDYNE and initiate appropriate therapy if an anaphylactic or other serious allergic reaction occurs during or following infusion. ( 5.4 ) 5.1 Local Adverse Reactions - Extravasation Standard precautions should be taken during infusion of VISUDYNE (verteporfin for injection) to avoid extravasation. Examples of standard precautions include, but are not limited to: • A free-flowing intravenous (IV) line should be established before starting VISUDYNE infusion and the line should be carefully monitored. • Due to the possible fragility of vein walls of some elderly patients, it is strongly recommended that the largest arm vein possible, preferably antecubital, be used for injection. • Small veins in the back of the hand should be avoided. Extravasation of VISUDYNE, especially if the affected area is exposed to light, can cause severe pain, inflammation, swelling or discoloration at the injection site. Localized (skin) necrosis at the injection site following extravasation has also been reported.

The following serious adverse reactions are described elsewhere in the labeling: • Local Adverse Reactions – Extravasation [see Warnings and Precautions ( 5.1 )] • Exposure to Sun or Direct Light [see Warnings and Precautions ( 5.2 )] • Decreased Vision after Treatment [see Warnings and Precautions ( 5.3 )] • Porphyria and Hypersensitivity [see Contraindications ( 4 )] Most common adverse reactions (incidence ˃10%) are injection site reactions and visual disturbances. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Severe chest pain, vasovagal and hypersensitivity reactions have been reported. Vasovagal and hypersensitivity reactions on rare occasions can be severe. These reactions may include syncope, sweating, dizziness, rash, dyspnea, flushing and changes in blood pressure and heart rate. General symptoms can include headache, malaise, urticaria, and pruritus.

8.1 Pregnancy Risk Summary There are no data with the use of VISUDYNE in pregnant women to inform a drug-associated risk. Intravenous administration of verteporfin to pregnant rats during the period of organogenesis produced an increase in the incidence of anophthalmia/microphthalmia and wavy ribs at exposures approximately 40-fold the human exposure at the recommended clinical dose. Verteporfin did not produce adverse fetal effect in rats or rabbits at exposures 6- to 20-fold the human exposure at the recommended clinical dose. There are no adequate and well-controlled studies in pregnant women. VISUDYNE should be used during pregnancy only if the benefit justifies the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. Data Animal Data Rat fetuses of dams administered verteporfin for injection intravenously during organogenesis exhibited an increase in the incidence of anophthalmia/microphthalmia and wavy ribs at doses ≥10 mg/kg/day (approximately 40-fold the human exposure at the recommended dose of 6 mg/m 2 , based on AUC in female rats). No teratogenic effects were observed in rat fetuses at a dose of 2 mg/kg/day (approximately 6-fold the human exposure at the recommended dose of 6 mg/m 2 , based on AUC in female rats).

Metabolism

Following intravenous infusion, verteporfin exhibits a bi-exponential elimination with a terminal elimination half-life of approximately 5-6 hours. The extent of exposure and the maximal plasma concentration are proportional to the dose between 6 and 20 mg/m 2 .

Overdose of drug and/or light in the treated eye may result in non-perfusion of normal retinal vessels with the possibility of severe decrease in vision that could be permanent. An overdose of drug will also result in the prolongation of the period during which the patient remains photosensitive to bright light. In such cases, it is recommended to extend the photosensitivity precautions for a time proportional to the overdose.

• Apr 12, 2000NDANDA021119Bausch Lomb Ireland

1. 1Visual Acuity Reduced40027%
2. 2Retinal Haemorrhage21314%
3. 3Disease Progression17312%
4. 4Off Label Use1409.5%
5. 5Polypoidal Choroidal Vasculopathy1349.1%
6. 6Choroidal Neovascularisation996.7%
7. 7Age-related Macular Degeneration875.9%
8. 8Retinal Pigment Epithelial Tear745.0%
9. 9Retinal Detachment664.5%
10. 10Vitreous Haemorrhage634.3%
11. 11Macular Degeneration594.0%
12. 12Detachment Of Retinal Pigment Epithelium583.9%
13. 13Condition Aggravated513.4%
14. 14Product Use In Unapproved Indication463.1%
15. 15Back Pain412.8%

Recent PubMed references pinned to Verteporfin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Construction of hepatic stellate cells-targeted nanosystem of verteporfin for the effective treatment of liver fibrosis through mechanical signal modulation.
  Nanotechnology · 2026 · Ma QQ, Wang L, Zhou SY, et al.
  PMID 42066797DOI 10.1088/1361-6528/ae6788
• Stabilizing lysosome to facilitate verteporfin-based anticancer photodynamic therapy via trehalose co-assembled nanogel.
  Colloids and surfaces. B, Biointerfaces · 2026 · Gou X, Li J, Yu Q, et al.
  PMID 41967448DOI 10.1016/j.colsurfb.2026.115696
• Long-Term Follow-Up of PLACE and SPECTRA Trials: Outcomes After Successful and Unsuccessful Half-Dose Photodynamic Therapy for Chronic Central Serous Chorioretinopathy.
  American journal of ophthalmology · 2026 · van den Tillaart FM, Chang-Wolf JM, Feenstra HMA, et al.
  PMID 41850667DOI 10.1016/j.ajo.2026.03.016
• Albumin-hitchhiking self-assembly full-API nanoparticles for imaging-guided photodynamic potentiating tumor immunotherapy.
  Biomaterials advances · 2026 · Gao W, Kang B, Xu S, et al.
  PMID 41747340DOI 10.1016/j.bioadv.2026.214776
• Copper-verteporfin coordination nanoparticles to reverse ferroptosis resistance in pancreatic cancer therapy.
  Nanoscale · 2026 · Jiang Z, Wang J, Ren H, et al.
  PMID 41672913DOI 10.1039/d5nr05059f
• In Silico Analysis of the Binding Mode of Verteporfin, a YAP-TEAD Interaction Inhibitor.
  Chemical & pharmaceutical bulletin · 2026 · Ikegami Y, Kudo G, Hirao T, et al.
  PMID 41672505DOI 10.1248/cpb.c25-00587
• DNA Nanoflower LYTACs Enable Efficient VEGF Degradation and Verteporfin Loading for Combined Therapy of Wet Age-Related Macular Degeneration.
  Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2026 · Li M, Yue Y, Wu S, et al.
  PMID 41603251DOI 10.1002/advs.202515852
• Verteporfin, an inhibitor of nuclear YAP, improved multi-ciliated cell differentiation in the airway epithelium.
  Journal of translational medicine · 2025 · Nakamura R, Kishimoto Y, Kita T, et al.
  PMID 41437370DOI 10.1186/s12967-025-07250-3

The 10 most recently updated of 107 ClinicalTrials.gov registrations naming Verteporfin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System
  Recruiting · Phase 1 · Phase 2 · Interventional · 43 enrolled · SpectraCure AB
  NCT06807359updated 2026-05-01
• Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System
  Recruiting · Phase 1 · Phase 2 · Interventional · 66 enrolled · SpectraCure AB
  NCT03067051updated 2026-05-01
• Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction
  Recruiting · Phase 1 · Phase 2 · Interventional · 42 enrolled · Roswell Park Cancer Institute
  NCT06306638updated 2026-04-06
• SCARFREE-001: Verteporfin for Scar Prevention
  Not yet recruiting · Phase 2 · Interventional · 12 enrolled · Odense University Hospital
  NCT07488988updated 2026-03-23
• Photoradiation With Verteporfin to Facilitate Immunologic Activity of Pembrolizumab in Unresectable, Locally Advanced or Metastatic Pancreatic Cancer
  Recruiting · Phase 2 · Interventional · 25 enrolled · Mayo Clinic
  NCT06381154updated 2026-01-30
• Ranibizumab and Reduced Fluence PDT for AMD
  Completed · Phase 2 · Interventional · 60 enrolled · Texas Retina Associates
  NCT00527475updated 2025-11-28
• Comparing Intravitreal Aflibercept Monotherapy vs Aflibercept Combined With Reduced Fluence PDT in PCV Treatment
  Completed · Interventional · 60 enrolled · Singapore National Eye Centre
  NCT03941587updated 2025-11-18
• Ultrasound-Guided Verteporfin Photodynamic Therapy for the Treatment of Unresectable Solid Pancreatic Tumors or Advanced Pancreatic Cancer, VERTPAC-02 Study
  Completed · Phase 2 · Interventional · 13 enrolled · Mayo Clinic
  NCT03033225updated 2025-07-30
• Effect of YAP1-inhibition in Surgical Wounds.
  Not yet recruiting · Phase 1 · Phase 2 · Interventional · 24 enrolled · Jöri Pünchera
  NCT06944249updated 2025-04-25
• Photodynamic Therapy Combined With Bevacizumab vs Bevacizumab Alone for Neovascular Age-related Macular Degeneration
  Withdrawn · Phase 2 · Interventional · 0 enrolled · University of Padova
  NCT00696592updated 2025-04-24

Frequently asked questions

How does Verteporfin work?

VISUDYNE (verteporfin for injection) therapy is a two-stage process requiring administration of both verteporfin for injection and nonthermal red light. Verteporfin is transported in the plasma primarily by lipoproteins.

What is Verteporfin used for?

According to FDA labeling, Verteporfin carries indications including: VISUDYNE ® (verteporfin for injection) therapy is indicated for the treatment of patients with predominantly classic subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD), pathologic myopia or presumed ocular histoplasmosis. There is insufficient evidence to indicate VISUDYNE for the treatment of predominantly occult subfoveal CNV.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Verteporfin?

Verteporfin is classified as Antineovascularisation agents, Photoenhancer, Photoabsorption, Decreased Endothelial Proliferation, Increased Endothelial Coagulation Activity, Increased Platelet Aggregation, Photosensitizing Activity.

What are the brand names for Verteporfin?

Verteporfin is marketed under brand names including Visudyne.

What are the contraindications for Verteporfin?

Verteporfin labeling lists contraindications including: VISUDYNE (verteporfin for injection) is contraindicated for patients with porphyria or a known hypersensitivity to any component of this preparation [see Adverse Reactions ( 6 )] . VISUDYNE (verteporfin for injection) is contraindicated for patients with porphyria or a known hypersensitivity to any component of this preparation.. Always consult the full prescribing information and a clinician.