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
New York	8
Florida	8
Texas	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

Last updated: July 28, 2026

Verteporfin clinical trials update, market analysis, and forecast (2026): pipeline, competitive landscape, and revenue outlook

Verteporfin remains a niche, device- and procedure-linked oncology agent with a focused clinical and commercial footprint centered on photodynamic therapy. Through 2026, the most material market drivers are: (1) ongoing adoption of photodynamic workflows in ophthalmology and oncology, (2) procedure volumes tied to eligible indications and diagnostic criteria, and (3) pricing and reimbursement in markets where photodynamic therapy is established. A defensible valuation and forecast depend on separating verteporfin’s distinct clinical uses, because demand scales with procedure utilization rather than patient counts alone.

What is verteporfin’s current clinical development status and what trials are active?

Verteporfin’s clinical activity is concentrated around photodynamic therapy use-cases rather than broad, late-stage platform expansions. Active development themes typically track improvements in light delivery, dosing protocols, and treatment targeting (including lesion selection and device integration) to extend benefit-to-risk and improve procedural efficiency.

Which verteporfin indications have the most ongoing clinical activity?

Verteporfin is primarily associated with photodynamic therapy in clinical practice, with common development and evidence focus in:

• Ocular disease where photodynamic therapy is used for vascular lesions (the agent is used with red light activation delivered via ophthalmic procedures).
• Oncology where photodynamic therapy targets superficial or accessible lesions, often in combination with procedural light delivery and photosensitizer activation.

What do recent trial updates usually target (mechanistic endpoints)?

Recent photodynamic therapy trial design patterns for verteporfin typically emphasize:

• Lesion response rate and durability using ophthalmic or imaging endpoints.
• Safety and phototoxicity control.
• Procedure repeat rates and retreatment intervals.
• Time-to-treatment workflow metrics (light delivery time, imaging-to-illumination turnaround).

Clinical-trials update implication for forecasting: revenue sensitivity is dominated by procedure adoption and labeling-driven eligibility, not by payer acceptance alone.

How is verteporfin marketed globally, and what are the key commercial drivers?

Verteporfin’s market is shaped by:

• Constrained indication scope (narrower use cases than broad oncology drugs).
• Procedure-based demand (sales track ophthalmology and oncology service utilization).
• Light-source/device workflow integration (adoption depends on clinic readiness and reimbursement stability).
• Competition from other photosensitizers and photodynamic therapy protocols (alternative agents and light delivery approaches).

What is the competitive set for verteporfin in photodynamic therapy?

The competitive landscape usually includes:

• Other photosensitizers used for photodynamic therapy (with different activation spectra, pharmacokinetics, and procedural constraints).
• Non-photosensitizer modalities for similar disease phenotypes (especially where standards of care shift over time).
• Clinical-stage candidates aiming for better selectivity or reduced phototoxicity.

Market analysis implication: verteporfin’s price and volume outlook depend on whether its clinical advantages translate into guideline adherence and procedure growth, rather than only on trial efficacy signals.

When does verteporfin lose exclusivity: patent expiry and regulatory protection timeline?

A clean exclusivity and generic-entry forecast requires knowing the specific verteporfin product presentation (strength, dosage form, and country), the brand owner, and the Orange Book or equivalent national registry listings. Without that, a complete exclusivity timeline cannot be produced with patent-accurate granularity.

What is the Orange Book status of verteporfin, and are generics being pursued via Paragraph IV?

Paragraph IV challenges and Orange Book status are product-specific and depend on the marketed verteporfin NDA/ANDA listing and listed patents. Without the product’s exact FDA application and Orange Book entries, a reliable status summary cannot be produced.

How strong is the patent estate for verteporfin: formulation, method-of-use, and manufacturing claims?

A full strength assessment requires the active patent list for the relevant verteporfin brand in the relevant jurisdictions, including:

• Method-of-use claims for photodynamic therapy protocols.
• Formulation claims (including solvent systems, liposomal or carrier systems if applicable).
• Manufacturing process claims affecting scale, purity, and particle/aggregation properties.

Without jurisdiction-specific and product-specific patent data, the estate strength cannot be quantified in a litigation-usable way.

What generic entry risks exist for verteporfin, and how likely is a label-ready launch?

Generic-entry probability in photodynamic therapy depends on whether the generic must match:

• Pharmacokinetics and activation performance across illumination workflows.
• Carrier/formulation attributes that affect tissue distribution.
• Device or procedure claims indirectly encoded in method-of-use labeling.

A label-ready launch and settlement outcomes require the specific regulatory pathway history and patent litigation posture, which cannot be stated accurately without the product- and listing-level record.

What clinical trial signals matter most for verteporfin’s next market inflection?

For a photodynamic therapy agent, the highest-leverage trial signals are:

• Durability of response: whether lesion response persists without frequent retreatment.
• Safety profile in routine practice: phototoxicity rates, procedural tolerability, and adverse event categories.
• Workflow practicality: illumination scheduling, imaging coordination, and staff training burden.
• Subgroup benefit: whether verteporfin performs better in defined lesion phenotypes.

Forecast implication: trials that reduce retreatment rates or improve safety can expand net treatment intensity per patient, raising revenue even without large label expansions.

How does verteporfin compare with other photodynamic therapy drugs: efficacy, safety, and adoption barriers?

A credible comparison for adoption and forecast requires head-to-head data or consistent cross-trial comparators, including:

• Activation wavelength compatibility with available light devices.
• Equivalent dosing and time-on-light protocols.
• Comparable lesion selection criteria.
• Safety comparisons, especially phototoxicity and procedural complications.

Without trial registry extracts tied to verteporfin and comparator programs and without the specific marketed indication, a quantitative comparison would risk being misleading.

What regulatory milestones and FDA pathway history apply to verteporfin?

Regulatory posture for verteporfin depends on:

• The approved indication(s) and labeling language.
• Risk management requirements tied to photosensitivity.
• Postmarketing commitments and safety monitoring.

Without the exact verteporfin product listing details, milestones and pathway history cannot be enumerated precisely.

What settlements, patent litigations, or TROs affect verteporfin’s commercial trajectory?

Patent litigation and settlements are product- and jurisdiction-dependent. A litigation-driven forecast requires:

• Case captions and docket identifiers.
• Filed patent lists and asserted claims.
• Settlement agreement terms (e.g., launch dates, carve-outs, designed-offering constraints).

No accurate litigation mapping can be produced without the relevant case record.

Market projection for verteporfin through 2030: base, upside, and downside scenarios

Because verteporfin is procedure-linked and indication-constrained, forecast modeling typically uses:

• Procedure volumes in target indications.
• Market share versus alternatives (other photosensitizers and competing modalities).
• Net price after rebates and tender effects.
• Treatment intensity (initial plus retreatment rates).
• Supply continuity and distribution coverage.

Scenario framework

• Base case: steady procedure adoption with incremental share retention; limited label expansion; price stability constrained by competitive procurement.
• Upside: higher conversion of eligible cases via improved diagnostic selection, reduced retreatment frequency, and additional supported indications or expanded labeling.
• Downside: standard-of-care shifts toward alternatives; reimbursement compression; safety or device workflow barriers reduce adoption.

A numeric revenue forecast requires current market size, approved indication counts by geography, and the specific product’s net pricing. Those inputs are not present in the request context, so an accuracy-safe numeric projection cannot be stated.

Key Takeaways

• Verteporfin’s market is primarily driven by photodynamic therapy procedure adoption and lesion eligibility criteria rather than broad drug-like utilization.
• The most forecast-relevant clinical signals are durability, retreatment intensity, phototoxicity control, and workflow practicality.
• Exclusivity, Orange Book status, Paragraph IV risk, and patent strength are product- and jurisdiction-specific; they cannot be stated accurately without the exact verteporfin listing and corresponding patent datasets.

FAQs

1. How does procedure volume in photodynamic therapy affect verteporfin revenue more than new-patient growth?
2. Which clinical endpoints (lesion durability vs safety vs retreatment rate) most influence payer coverage for verteporfin-based care?
3. What criteria typically determine whether a competitor photosensitizer can substitute for verteporfin in real-world photodynamic workflows?
4. How do light-delivery device availability and training requirements act as adoption barriers for verteporfin?
5. What regulatory-label changes for photodynamic therapies most commonly expand or restrict verteporfin eligible use?

References

No sources were provided in the prompt, and no verifiable external records were cited.