VISUDYNE (verteporfin)
VISUDYNE is indicated for the treatment of Choroidal Neovascularization; Age-Related Macular Degeneration; Pathologic Myopia; Ocular Histoplasmosis.
How VISUDYNE Works
Visudyne therapy is a two-stage process requiring the intravenous administration of the drug followed by activation with nonthermal red light. Once activated in the presence of oxygen, the drug generates highly reactive singlet oxygen and reactive oxygen radicals. These species cause local damage to the neovascular endothelium, triggering the release of procoagulant and vasoactive factors that lead to platelet aggregation, fibrin clot formation, and vasoconstriction. While the drug accumulates preferentially in abnormal neovasculature, it is also present in the retina; therefore, photoactivation may cause collateral damage to retinal structures, specifically the retinal pigmented epithelium (RPE) and the outer nuclear layer.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2000-04-12
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
VISUDYNE Approval History
What VISUDYNE Treats
4 indicationsVISUDYNE is approved for 4 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Choroidal Neovascularization
- Age-Related Macular Degeneration
- Pathologic Myopia
- Ocular Histoplasmosis
VISUDYNE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03067051 | SPC11-01-110 | Ph 1, Ph 2 | recruiting | Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System |
| NCT06306638 | I-3901323 NCI-2024-01239, I-3901323 | Ph 1, Ph 2 | recruiting | Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction |
| NCT06381154 | MC230404 NCI-2024-03078, 23-009036 | Ph 2 | recruiting | Photoradiation With Verteporfin to Facilitate Immunologic Activity of Pembrolizumab in Unresectable, Locally Advanced or Metastatic Pancreatic Cancer |
| NCT03033225 results posted | 16-001243 NCI-2019-07003, 16-001243 | Ph 2 | completed | Ultrasound-Guided Verteporfin Photodynamic Therapy for the Treatment of Unresectable Solid Pancreatic Tumors or Advanced Pancreatic Cancer, VERTPAC-02 Study |
| NCT04590664 | STUDY00000974 NCI-2020-05187, WINSHIP5070-20 | Ph 1, Ph 2 | recruiting | Verteporfin for the Treatment of Recurrent High Grade EGFR-Mutated Glioblastoma |
| NCT04075136 | IRB00058375 | Ph 4 | withdrawn | Optical Coherence Tomography Angiography (OCTA) - Directed PDT Triple Therapy |
| NCT02702700 PDT-lipo | CHUV-DO-PDT-2015 | Ph 1 | terminated | Photo-induction as a Means to Improve Cisplatin Delivery to Pleural Malignancies |
| NCT02464761 | PDT01 | Ph 1 | completed | Photodynamic Therapy for the Treatment of Vertebral Metastases |
| NCT01482910 results posted | 13406 | Ph 3 | completed | VEGF Trap-Eye: Investigation of Efficacy and Safety in Chinese Subjects With Wet AMD (Age-Related Macular Degeneration) |
| NCT01325181 results posted | NOV001 | Ph 1, Ph 2 | completed | Ranibizumab Versus Low-fluence Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VISUDYNE FDA Label Details
Indications & Usage
FDA Label (PDF)VISUDYNE is indicated for the treatment of Choroidal Neovascularization; Age-Related Macular Degeneration; Pathologic Myopia; Ocular Histoplasmosis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment