CLINICAL TRIALS PROFILE FOR VERTEPORFIN

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.
NCT00049959 ↗	Two Studies to Determine if Verteporfin PDT is Effective & Safe in Treating Multiple Basal Cell Carcinoma of the Skin.	Terminated	QLT Inc.	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.

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

Condition MeSH

Condition MeSH for verteporfin
Intervention	Trials
Macular Degeneration	40
Choroidal Neovascularization	21
Neovascularization, Pathologic	17
Wet Macular Degeneration	8

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

Trials by US State

Trials by US State for verteporfin
Location	Trials
California	9
Texas	8
New York	8
Florida	8
Pennsylvania	7

Clinical Trial Progress for verteporfin

Clinical Trial Phase

Clinical Trial Phase for verteporfin
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	3
Phase 4	11

Clinical Trial Status

Clinical Trial Status for verteporfin
Clinical Trial Phase	Trials
Completed	44
Unknown status	9
Recruiting	8

Clinical Trial Sponsors for verteporfin

Sponsor Name

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

Sponsor Type

Sponsor Type for verteporfin
Sponsor	Trials
Other	60
Industry	37
NIH	7

Verteporfin: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

Introduction

Verteporfin, a photosensitizing agent primarily marketed under the brand name Visudyne, plays a crucial role in the treatment of wet age-related macular degeneration (AMD). Its mechanism involves targeting abnormal blood vessels in the retina, followed by laser activation to induce vascular occlusion. As ophthalmology advances and new therapeutic developments emerge, understanding Verteporfin’s current clinical landscape, market dynamics, and future trajectory becomes essential for stakeholders in pharmaceutical and healthcare sectors.

Clinical Trials Landscape

Historical and Current Clinical Data

Since its FDA approval in 2000, Verteporfin has undergone extensive clinical evaluation. Key pivotal studies, including the TAP (Treatment of Age-related Macular Degeneration with Photodynamic Therapy) and VIP ( Verteporfin in Photodynamic Therapy) trials, established its efficacy and safety profile in managing neovascular AMD. These studies demonstrated that Verteporfin, when combined with cold laser therapy, can slow the progression of vision loss in certain patient subsets.

In recent years, the utilization of Verteporfin has shifted, reflecting evolving treatment paradigms. The advent of anti-VEGF therapies has somewhat reduced its use; however, it remains a vital option—particularly in cases where patients are contraindicated for or unresponsive to anti-VEGF agents.

Ongoing and Future Clinical Trials

Despite its longstanding use, current clinical investigations are comparatively limited. Nonetheless, some trials focus on optimizing treatment protocols, combination therapies, and expanding indications. For instance, trials are exploring Verteporfin’s applicability in:

• Polypoidal Choroidal Vasculopathy (PCV): A subtype of AMD, prevalent in Asian populations, with studies recommending Verteporfin as an effective PDT (photodynamic therapy) agent [1].
• Preclinical research into its efficacy in other ocular neovascular conditions.

Most recent trials aim to refine dosing schedules, assess long-term safety, and evaluate combination therapies with emerging agents—including newer anti-angiogenic drugs and gene therapies.

Market Analysis

Market Size and Revenue Trends

The global ophthalmic therapeutics market, driven by the increasing prevalence of AMD and retinal vascular diseases, stood at approximately USD 12 billion in 2022, with a compound annual growth rate (CAGR) of around 4.5% projected through 2030 [2]. Within this landscape, Verteporfin’s market share has experienced relative stability, supported by its FDA approval and established clinical use.

According to industry reports, the Visudyne product line generated revenues exceeding USD 1.2 billion annually before the market's significant shift towards anti-VEGF therapies. The decline in its relative market dominance reflects broader trend shifts, yet its niche applications sustain ongoing demand, particularly in Asian markets where PCV prevalence is higher.

Competitive Landscape

The ophthalmic niche involving PDT agents faces competitive pressures from newer therapies, especially anti-VEGF injections such as ranibizumab, aflibercept, and brolucizumab. However, Verteporfin maintains competitive advantages in:

• Specific indications like PCV, where PDT remains a preferred treatment.
• Use in combination therapies to optimize outcomes.
• Cost-effectiveness in resource-limited settings.

Biotech firms are investigating next-generation photosensitizers and light-activated drugs, potentially challenging Verteporfin’s market position over time.

Regulatory Environment and Market Expansion Opportunities

While Verteporfin is approved primarily for ocular indications, research into its systemic applications—such as some cancers and dermatologic conditions—remains limited and exploratory. Regulatory adaptations, including expanded indications, could unlock additional markets.

Emerging markets show growth potential, especially in Asia-Pacific, where age-related retinal diseases are increasing. Regulatory pathways in these regions are evolving, creating avenues for renewed commercial activity, especially if combination therapies or new delivery systems are developed.

Future Market Projections

Based on current clinical trends, competitive dynamics, and emerging research:

• Short-term outlook (1–3 years): Verteporfin’s market will stabilize with minor declines due to the dominance of anti-VEGF therapies. Its role as a secondary or adjunctive treatment, especially for PCV, is expected to sustain steady demand.
• Medium-term outlook (3–7 years): Innovations in delivery systems, including nanoparticle-based formulations and combination therapies, could revitalise its clinical applications and market share.
• Long-term outlook (7+ years): The overall decline is anticipated unless enhanced efficacy, broader indications, or new formulations emerge. Market consolidation may occur as newer agents replace PDT in standard protocols.

Strategic Implications for Stakeholders

• Pharmaceutical Companies: Focus on developing next-generation PDT agents or combination treatments integrating Verteporfin to maintain relevance.
• Investors: Monitor clinical trial pipelines targeting PDT modifications or expanded indications, especially in the Asian ophthalmic markets.
• Healthcare Providers: Continue to recognize Verteporfin as a valuable option for specific cases, notably PCV.

Key Takeaways

• Verteporfin has transitioned from a frontline AMD therapy toward niche applications, notably in PCV and combination regimens.
• Clinical trials are principally aimed at optimizing existing protocols and exploring new indications, with limited high-impact studies in recent years.
• Market revenues are stable but declining modestly, impacted by anti-VEGF therapies’ dominance.
• The growth outlook hinges on innovations in drug delivery, expanded indications, and market expansion in Asia-Pacific.
• Strategic positioning requires continuous evaluation of clinical and regulatory developments to leverage niche markets effectively.

FAQs

1. Will Verteporfin remain relevant in AMD treatment?
While anti-VEGF therapies are now preferred for typical neovascular AMD, Verteporfin retains relevance for PCV and specific cases where patients are unsuitable for injections. Its niche applications ensure continued clinical utility.

2. Are there ongoing clinical trials that could expand Verteporfin’s indications?
Current trials focus more on optimizing existing protocols rather than expanding indications. However, preclinical research and niche studies suggest potential for broader applications, especially in retinal vascular diseases.

3. How does Verteporfin compare cost-wise to anti-VEGF therapies?
Verteporfin’s treatment costs are generally lower than regular anti-VEGF injections. Its cost-effectiveness makes it an attractive option in resource-constrained settings, particularly for PCV treatment.

4. What are the main competitors of Verteporfin in the PDT space?
Other PDT agents are under development, but none currently rival Verteporfin’s established clinical profile. The primary competitors are emerging laser-based or combination therapies rather than direct pharmaceutical rivals.

5. What is the outlook for Verteporfin in non-ocular indications?
Research in systemic applications remains limited. Significant clinical breakthroughs would require robust evidence of efficacy and safety, which at present remains exploratory.

Sources

1. Souied EH, et al. Treatment of Polypoidal Choroidal Vasculopathy with Verteporfin: A Review. Ophthalmology. 2021.
2. MarketsandMarkets. Ophthalmic Drugs Market by Product, Indication, End-User, and Region — Global Forecast to 2030. 2022.