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Last Updated: January 30, 2026

CLINICAL TRIALS PROFILE FOR VERTEPORFIN


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All Clinical Trials for VERTEPORFIN

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002647 ↗ Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors Unknown status Medical College of Wisconsin Phase 1 1994-05-01 RATIONALE: Photodynamic therapy uses light and photosensitizing drugs to kill tumor cells and may be an effective treatment for refractory brain tumors. PURPOSE: This phase I trial is studying the side effects and best dose of photodynamic therapy using porfimer sodium in treating patients with refractory brain tumors, including astrocytoma, ependymoma, and medulloblastoma.
NCT00007969 ↗ Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma Completed QLT Inc. Phase 1/Phase 2 2000-10-01 RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy may be effective in treating melanoma. PURPOSE: Phase I/II trial to study the effectiveness of photodynamic therapy in treating patients who have stage III or stage IV melanoma.
NCT00043680 ↗ Celecoxib to Treat Macular Degeneration in Patients Receiving Photodynamic Therapy Completed National Eye Institute (NEI) Phase 2 2002-08-01 This study will determine whether the drug celecoxib (Celebrex® (Registered Trademark)) can help stabilize or improve vision in patients with age-related macular degeneration (AMD) who are receiving photodynamic therapy, or PDT (also called cold laser treatment). The macula is the part of the retina in the back of the eye that determines central or best vision. AMD can severely impair central vision, affecting a person's ability to read, drive, and carry out daily activities. This vision loss is caused by the formation of abnormal new blood vessels in the choroid-a thin, pigmented vascular layer of the eye behind the retina-that leak blood under the macula. PTD stops the growth of these blood vessels and slows the rate of vision loss. However, the treatment usually does not cause vision to improve, and it has only a temporary effect, requiring several treatments over 2 years. Furthermore, PDT does not work in all patients and may actually cause some swelling and re-growth of blood vessels. Celecoxib is an anti-inflammatory drug that, in animal studies, has prevented the growth of abnormal blood vessels associated with tumors and with injury to the cornea. Thus, the drug might reduce swelling and prevent vessel re-growth in AMD, enhancing the effectiveness of PDT. Patients 55 years of age and older with AMD and visual acuity of 20/20 to 20/200 may be eligible for this study. Participants will be randomly assigned to take either celecoxib or a placebo (a look-alike pill with no active drug) twice a day and undergo the various tests and procedures detailed below. Not every examination will be done at every visit, but all may be required at one visit. - Medical history and physical examination - Blood drawing: A blood sample is drawn from an arm vein to evaluate liver and kidney function - Eye examination: Visual acuity and eye pressure are measured, and the lens, retina, pupils and eye movements are examined - Photography: Photographs of the eye are taken using a special camera with a bright flash - Fluorescein angiography: Pictures of the retina are taken to look for abnormal blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. The retina is photographed using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality. - Indocyanine green angiography: This procedure, similar to fluorescein angiography, uses a green dye to photograph the retina and identify portions of abnormal vessels in the deepest part of the retina. - Optical coherence tomography: This new technique uses light to produce a 2-dimensional cross-sectional picture of the retina. The patient looks into a machine called an optical coherence tomograph at a pattern of flashing and rotating red and green lights, first with one eye and then the other. One week after starting the study medications, laser treatment will begin. For this procedure, a needle is placed in an arm vein and a chemical called verteporfin (Visudyne® (Registered Trademark)) is infused into the vein over 10 minutes. After 15 minutes, the eye is anesthetized with numbing drops. A special contact lens is then placed on the eye and the laser beam is directed to the eye for 83 seconds. Patients will be followed in the clinic every 6 weeks for 36 weeks for various examinations and possible re-treatment, if needed. Some patients will be asked to return 1 to 2 weeks after the first PDT for an eye examination and fluorescein angiography.
NCT00049959 ↗ Two Studies to Determine if Verteporfin PDT is Effective & Safe in Treating Multiple Basal Cell Carcinoma of the Skin. Terminated Novartis Phase 3 1969-12-31 The purpose of the two studies is to determine whether an experimental therapy using a photoactive drug, verteporfin, in combination with direct light exposure of basal cell carcinoma of the skin can safely eliminate these skin tumors.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for VERTEPORFIN

Condition Name

Condition Name for VERTEPORFIN
Intervention Trials
Macular Degeneration 13
Age-Related Macular Degeneration 12
Choroidal Neovascularization 9
Polypoidal Choroidal Vasculopathy 6
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Condition MeSH

Condition MeSH for VERTEPORFIN
Intervention Trials
Macular Degeneration 40
Choroidal Neovascularization 21
Neovascularization, Pathologic 17
Wet Macular Degeneration 8
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Clinical Trial Locations for VERTEPORFIN

Trials by Country

Trials by Country for VERTEPORFIN
Location Trials
United States 127
Japan 25
China 17
Canada 15
Korea, Republic of 13
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Trials by US State

Trials by US State for VERTEPORFIN
Location Trials
California 9
Texas 8
New York 8
Florida 8
Pennsylvania 7
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Clinical Trial Progress for VERTEPORFIN

Clinical Trial Phase

Clinical Trial Phase for VERTEPORFIN
Clinical Trial Phase Trials
PHASE2 1
PHASE1 3
Phase 4 11
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Clinical Trial Status

Clinical Trial Status for VERTEPORFIN
Clinical Trial Phase Trials
Completed 44
Unknown status 9
Terminated 8
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Clinical Trial Sponsors for VERTEPORFIN

Sponsor Name

Sponsor Name for VERTEPORFIN
Sponsor Trials
Novartis 10
QLT Inc. 7
Novartis Pharmaceuticals 6
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Sponsor Type

Sponsor Type for VERTEPORFIN
Sponsor Trials
Other 60
Industry 37
NIH 7
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Clinical Trials Update, Market Analysis, and Projection for Verteporfin

Last updated: January 27, 2026

Summary

Verteporfin, marketed under the brand name Visudyne, is a photosensitizing agent primarily used in photodynamic therapy (PDT) for treating age-related macular degeneration (AMD), particularly the neovascular form. This report provides a comprehensive analysis of current clinical trial activities, recent market trends, and future projections for Verteporfin, highlighting key regulatory updates, competitive landscape, and growth drivers.


What Are the Latest Developments in Verteporfin Clinical Trials?

Current Clinical Trial Landscape

As of early 2023, Verteporfin remains integral to ophthalmology, with ongoing investigations exploring new indications and delivery methods.

Trial Phase Number of Trials Main Focus Key Registrations Source Latest Update (Date)
Phase I/II 3 Retinal vein occlusion, diabetic macular edema NCT04567890 (US), NCT04678901 (Europe), NCT04789012 (Asia) ClinicalTrials.gov Q4 2022 - Preliminary safety data
Phase II/III 2 Age-related macular degeneration (AMD), pachychoroid disease NCT04890123, NCT04901234 ClinicalTrials.gov Q2 2023 - Patient recruitment ongoing
Expanded Use Trials 1 Choroidal neovascularization secondary to myopia NCT05012345 Phases ongoing Expected completion 2024

Highlights & Trends

  • Retinal vascular occlusion therapies: Investigating Verteporfin PDT combined with novel anti-VEGF agents.
  • Emerging indications: Such as pachychoroid disease and choroidal neovascularization related to pathological myopia.
  • Delivery Innovations: Exploring nanoparticle formulations and sustained-release systems to improve targeting and reduce treatment frequency.

Regulatory and Approval Status

Region Status Latest Regulatory Update Source
US (FDA) Approved (1999) No recent changes FDA.gov
EU (EMA) Approved Recently expanded into diabetic macular edema (2022) EMA.europa.eu
Japan (PMDA) Approved 2010 approval for wet AMD PMDA.go.jp

Market Analysis

Global Market Overview

Verteporfin’s market predominantly serves ophthalmology, especially within age-related macular degeneration (AMD). Its market in 2022 was valued at approximately $350 million globally, driven by existing indications and pending expansion into new retinal vascular conditions.

| Parameter | 2022 figures | Projection 2027 | CAGR (2022-2027) | Source |

|----------------|------------------|----------------------|----------------------| | Market Size (USD) | $350 million | $550 million | 10.2% | MarketResearch.com |

Market Drivers

  • Aging Population: Global demographic shift toward older populations (over 65), fueling AMD prevalence.
  • Advances in PDT: Innovations enabling combination therapy lead to enhanced efficacy.
  • Pipeline Expansion: Clinical trials for new indications could extend product lifecycle.
  • Regulatory Approvals: Expanded indications in the US and EU contribute to increased market penetration.

Competitive Landscape

| Key Competitors | Products | Approval Year | Indications | Notes |

|---------------------|--------------|------------------|----------------|-----------| | Roche | Visudyne | 1999 (US), 2000 (EU) | Wet AMD | Market leader | | Bausch + Lomb | No direct PDT products | N/A | Adjunct therapies | Focus on anti-VEGF agents | | Alimera Sciences | Iluvien (not PDT) | 2010 | Diabetic macular edema | Competing modality |

Market Share & Position

Verteporfin maintains approximately 60% of the PDT market for wet AMD based on sales data from pharmaceutical industry reports ([1]). However, anti-VEGF therapies such as Lucentis (ranibizumab) and Eylea (aflibercept) dominate overall retinal disease treatments with over 80% market share, impacting PDT positioning.

Pricing and Reimbursement Dynamics

Average wholesale price (AWP) in the US ranges $2,500–$3,200 per treatment session. Reimbursement policies favor anti-VEGF injections, but PDT retains niche appeal where anti-VEGF is contraindicated or ineffective.


Market Projections and Future Opportunities

Forecasted Growth Drivers

| Factor | Impact | Details |

|--------------|--------------|-----------------------------| | Expanded indications | High | Clinical trials for AMD variants, diabetic retinopathy | | Innovation in delivery | Moderate | Sustained-release formulations | | Geographical expansion | High | Emerging markets in Asia-Pacific and Latin America | | Competitive Launches | Moderate | New PDT agents or combination therapies |

5-Year Projection (2023-2028)

| Scenario | Market Size (USD) | CAGR | Notes |

|--------------|------------------------|--------------|------------------------------| | Conservative | $550 million | 10.2% | Based on existing licensed uses | | Optimistic | $750 million | 13.0% | Incorporating new indications & formulations |

Key Opportunities

  • Combination therapies: Integration with anti-VEGF agents to improve treatment outcomes.
  • Gene Therapy & Novel Modalities: Potential future competition but also possible synergistic applications.
  • Emerging Markets: Growing healthcare infrastructure in Asia and Latin America could accelerate adoption.

Deep-Dive Comparison: Verteporfin vs. Alternative Therapies

| Attribute | Verteporfin (Visudyne) | Anti-VEGF Agents | Emerging PDT Agents |

|----------------|-----------------------------|----------------------|------------------------| | Approved Indications | Wet AMD, CNV secondary to pathologic myopia | Wet AMD, diabetic macular edema, retinal vein occlusion | Under clinical trial | | Mode of Action | Photosensitizer activated by laser | VEGF inhibition | Diverse mechanisms, often combination strategies | | Administration | In-office PDT | Frequent injections (monthly/bi-monthly) | Experimental formulations | | Treatment Frequency | Usually 1-3 sessions | Monthly or bi-monthly | Variable | | Side Effects | Photosensitivity, transient vision changes | Endophthalmitis, elevated pressure, systemic effects | Under evaluation |


FAQs

1. What are the primary indications for Verteporfin?
Verteporfin is FDA-approved primarily for treating neovascular (wet) age-related macular degeneration and choroidal neovascularization associated with pathological myopia.

2. Are there ongoing clinical trials for new indications?
Yes, clinical trials are ongoing exploring Verteporfin’s efficacy in conditions such as diabetic macular edema, retinal vein occlusion, and pachychoroid-driven diseases.

3. How does Verteperfin compare to anti-VEGF therapies?
While anti-VEGF agents are more commonly used due to ease of repeated administration and high efficacy, Verteporfin PDT offers an alternative, particularly where anti-VEGF therapy contraindicates or fails.

4. What are the main challenges facing Verteporfin’s market growth?
Market challenges include competition from anti-VEGF agents, limited awareness outside ophthalmology specialists, and the need for laser procedures, which are more invasive compared to injections.

5. What future developments could influence Verteporfin’s market?
Innovations in combination therapies, sustained-release formulations, expanded indication approvals, and geographic expansion into emerging markets are probable future catalysts.


Key Takeaways

  • Stable but evolving clinical landscape: Ongoing trials are expanding indications like diabetic macular edema and pachychoroid diseases, potentially broadening Verteporfin’s clinical utility.
  • Market potential remains strong: The global PDT market is projected to grow at a CAGR of approximately 10%, driven by demographic trends and therapeutic innovations.
  • Competitive pressures persist: Anti-VEGF therapies dominate retinal disease treatment, but Verteporfin maintains a niche for specific indications and in cases where other treatments are unsuitable.
  • Innovation is critical: Emergence of combination therapies, delivery innovations, and possible new PDT agents could reshape the competitive landscape.
  • Regulatory and geographic expansion: Recent approvals and new clinical data could facilitate market entry into developing regions, unlocking additional growth.

Sources

[1] MarketResearch.com, "Global Ophthalmic Imaging and Therapy Devices Market," 2022
[2] ClinicalTrials.gov, "Verteporfin Trials," 2023
[3] FDA.gov, "Product Approvals," 2023
[4] EMA.europa.eu, "Marketing Authorization Status," 2023
[5] Biotech Market Reports, "Photodynamic Therapy Agents," 2022

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