CLINICAL TRIALS PROFILE FOR VISUDYNE

All Clinical Trials for Visudyne

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00021736 ↗	Phase II/III Study of Anti-VEGF in Neovascular AMD	Completed	Eyetech Pharmaceuticals	Phase 2/Phase 3	2001-07-01	The purpose of the study is to determine whether the anti-VEGF drug is effective at stabilizing and/or improving vision in patients with the wet form of AMD
NCT00041483 ↗	Phase 3 Study to Evaluate Anecortave Acetate vs. Visudyne for the Treatment of the Wet Form of AMD	Completed	Alcon Research	Phase 3	2002-06-01	The purpose of this study is to demonstrate that Anecortave Acetate is as effective after twelve months of treatment as photodynamic therapy (PDT) with Visudyne in patients eligible for initial PDT treatment for wet age-related macular degeneration.
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.
NCT00056823 ↗	Intravitreal Injections of rhuFab V2 in Combination With Visudyne in Subjects With Age Related Macular Degeneration (AMD)	Completed	Genentech, Inc.	Phase 1/Phase 2	2003-03-01	The primary purpose of this study is to determine if injections of rhuFab V2 into the eye in combination with verteporfin photodynamic therapy (PDT) is a safe and efficacious treatment for patients with age-related macular degeneration.

Clinical Trial Conditions for Visudyne

Condition Name

Condition Name for Visudyne
Intervention	Trials
Macular Degeneration	15
Choroidal Neovascularization	12
Age-Related Macular Degeneration	7
Age Related Macular Degeneration	4

Condition MeSH

Condition MeSH for Visudyne
Intervention	Trials
Macular Degeneration	37
Choroidal Neovascularization	19
Neovascularization, Pathologic	17
Wet Macular Degeneration	8

Clinical Trial Locations for Visudyne

Trials by Country

Trials by Country for Visudyne
Location	Trials
United States	101
China	22
Japan	20
Canada	14
India	8

Trials by US State

Trials by US State for Visudyne
Location	Trials
Texas	7
New York	7
California	6
Maryland	6
Arizona	5

Clinical Trial Progress for Visudyne

Clinical Trial Phase

Clinical Trial Phase for Visudyne
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	11
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Visudyne
Clinical Trial Phase	Trials
Completed	36
Unknown status	8
Terminated	5

Clinical Trial Sponsors for Visudyne

Sponsor Name

Sponsor Name for Visudyne
Sponsor	Trials
Novartis	7
QLT Inc.	6
Novartis Pharmaceuticals	5

Sponsor Type

Sponsor Type for Visudyne
Sponsor	Trials
Other	41
Industry	39
NIH	4

VISUDYNE (Verteporfin): Clinical Trials, Market Analysis, and Projections

Last updated: January 1, 2025

Introduction to VISUDYNE

VISUDYNE (verteporfin for injection) is a photoenhancer 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. Here, we delve into the clinical trials, market analysis, and future projections for this critical therapeutic agent.

Clinical Trials and Efficacy

Treatment Outcomes

Clinical trials have demonstrated the efficacy of VISUDYNE in reducing leakage and neovascular lesions associated with wet AMD. For instance, studies have shown that VISUDYNE significantly reduces disease progression compared to placebo groups. Specifically, disease progression was observed in 23% of VISUDYNE patients, compared to 54% in the placebo group[1].

Vascular Leakage Reduction

The therapy has also been effective in reducing vascular leakage. Approximately 51% of patients treated with VISUDYNE had no vascular leakage, in contrast to 29% of patients on placebo[1].

Early and Sustained Improvement

Improvements in patient conditions have been observed as early as 3 months after the initial treatment, and clinical benefits have been sustained for up to 2 years after initiation of therapy[4].

Market Analysis

Global Market Segmentation

The global verteporfin market is segmented by region, including North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. North America and Europe are significant markets due to the high prevalence of age-related macular degeneration (AMD) in these regions. For example, around 11 million individuals in the U.S. are affected by AMD, and at least 33.6 million individuals above 60 years are affected in Europe[2][5].

Key Players

The market is dominated by key players such as Bausch Health Companies Inc., Cheplapharm Arzneimittel, Novartis AG, Novelion Therapeutics Inc., Ciba Corporation, and LGM Pharma, LLC. These companies are involved in various strategic agreements and acquisitions to strengthen their market share. For instance, Cheplapharm Arzneimittel acquired the worldwide rights (except for the U.S.) for VISUDYNE from Novartis Pharma AG in 2018[2].

Regional Growth Drivers

The growth of the global verteporfin market is driven by the increasing burden of AMD and other related conditions. In North America, agreements between companies like Bausch + Lomb and Modulight to develop novel lasers for photodynamic therapy have accelerated market growth. Similarly, in Europe, pharmaceutical companies are focusing on acquisitions and mergers to enhance their market presence[2][5].

Market Projections

Future Growth

The global verteporfin market is expected to grow significantly due to the increasing prevalence of age-related macular degeneration and other indications. The market is anticipated to benefit from advancements in photodynamic therapy and the development of novel lasers specifically designed for use with VISUDYNE.

Supply Chain Improvements

Recent supply chain issues, such as the shortage of VISUDYNE from May 2020 to Q1 2022, have been addressed through the transfer of manufacturing to alternative production lines and the importation of bulk products from the U.S. These measures are expected to stabilize the supply and support market growth[3].

Supply Shortage Management

Recent Shortage and Resolution

A significant supply shortage of VISUDYNE occurred from May 2020, which was managed through controlled distribution systems and the importation of limited quantities from the U.S. The shortage was resolved by the end of Q1 2022, with CHEPLAPHARM prioritizing the distribution of newly manufactured VISUDYNE to affected member states[3].

Regulatory and Safety Information

Important Safety Information

Healthcare professionals are advised to report any negative side effects of VISUDYNE to the FDA. The therapy is contraindicated for patients with predominantly occult subfoveal CNV due to insufficient evidence of its efficacy in such cases[1][4].

Key Takeaways

• Efficacy in Clinical Trials: VISUDYNE has shown significant reduction in disease progression and vascular leakage in patients with wet AMD.
• Market Segmentation: The global verteporfin market is segmented by region, with North America and Europe being key markets.
• Key Players: Companies like Bausch Health, Cheplapharm Arzneimittel, and Novartis AG are major players in the market.
• Future Growth: The market is expected to grow due to increasing prevalence of AMD and advancements in photodynamic therapy.
• Supply Chain: Recent supply shortages have been addressed, and measures are in place to ensure stable supply.

FAQs

What is VISUDYNE used for?

VISUDYNE (verteporfin for injection) is used for the treatment of patients with predominantly classic subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration, pathologic myopia, or presumed ocular histoplasmosis.

How effective is VISUDYNE in clinical trials?

VISUDYNE has been shown to reduce disease progression and vascular leakage significantly. For example, 51% of patients treated with VISUDYNE had no vascular leakage, compared to 29% of patients on placebo[1].

What regions are key markets for the global verteporfin market?

North America and Europe are significant markets due to the high prevalence of age-related macular degeneration (AMD) in these regions[2][5].

Who are the key players in the global verteporfin market?

Key players include Bausch Health Companies Inc., Cheplapharm Arzneimittel, Novartis AG, Novelion Therapeutics Inc., Ciba Corporation, and LGM Pharma, LLC[2].

How was the recent supply shortage of VISUDYNE managed?

The supply shortage was managed through controlled distribution systems, the transfer of manufacturing to alternative production lines, and the importation of limited quantities from the U.S. The shortage was resolved by the end of Q1 2022[3].

Sources

1. Bausch & Lomb. VISUDYNE (verteporfin for injection) therapy.
2. Coherent Market Insights. Verteporfin Market - Share, Size and Industry Analysis.
3. AIFA. Direct communication with healthcare professionals on Visudyne (verteporfin).
4. Bausch & Lomb. Treat persistent retinal fluid with VISUDYNE.
5. Coherent Market Insights. Verteporfin Market Regional Analysis.