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Visudyne

(Verteporfin)

ApprovedSmall molecule

BBausch Health Americas, Inc.

Verteporfin is used to treat a type of age-related macular degeneration (a disease that causes vision loss in older people) by being injected into the bloodstream and then activated by a laser to destroy abnormal blood vessels in the eye.[2] Visudyne is currently approved and in use across 25 indications[4].[1]

Visudyne is one of 462 small molecule programs targeting Pancreatic Neoplasm. It is currently in Approved.

25

Indications

27

Total Trials

8

Active Trials

461

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Pancreatic NeoplasmApproved

Chronic Central Serous RetinopathyApproved

Choroidal NeovascularizationApproved

Glioblastoma MultiformeApproved

Nevoid Basal Cell Carcinoma SyndromeApproved

Cutaneous MelanomaApproved

Pathological MyopiaActive, not recruiting

Ocular Vascular DiseaseActive, not recruiting

Psoriasis VulgarisActive, not recruiting

Breast NeoplasmActive, not recruiting

Pancreatic NeoplasmApproved

Approved

Chronic Central Serous RetinopathyApproved

Approved

Choroidal NeovascularizationApproved

Approved

Glioblastoma MultiformeApproved

Approved

Nevoid Basal Cell Carcinoma SyndromeApproved

Approved

Cutaneous MelanomaApproved

Approved

Pathological MyopiaApproved

Active, not recruiting

Ocular Vascular DiseaseApproved

Active, not recruiting

Psoriasis VulgarisApproved

Active, not recruiting

Breast NeoplasmPreclinical

Active, not recruiting

Showing 10 of 25 indications

Competition

Competitive Landscape

348 competitors in Prostate Cancer

#DrugCompanyPhaseTrials

Visudyne

BBausch Health Americas, Inc.

Paraplatin

Tecentriq

Nizoral

Alinamin

Ritalin

Xaluritamig

Perflutren Lipid Microspheres

SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Trexall

Jazz Pharmaceuticals

Ranexa

MMenarini International Operations Luxembourg SA

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1/2Recruiting

Safety and Efficacy

NCT03067051

Q1 2028

Phase 2Not yet recruiting

Prevention

NCT07488988

Q1 2029

Phase 1/2Recruiting

Prostate Cancer

NCT06807359

Q4 2029

Phase 1/2Recruiting

Airway Obstruction

NCT06306638

Phase 2Recruiting

Pancreatic Cancer

NCT06381154

Clinical

Trials by Indication[1]

Retinopathy3 trials

Ranibizumab Versus Low-fluence Photodynamic Therapy in the Treatment of Chronic Central Serous Chorioretinopathy

Completed·JJang Won Heo·Phase 1/2·NCT01325181·34 enrolled

Choroidal Blood Flow in Acute and Chronic Central Serous Chorioretinopathy

Recruiting·HHelse Stavanger HF··NCT05589974·50 enrolled

Photodynamic Therapy Using Verteporfin for Treatment of Chronic Central Serous Chorioretinopathy (CSC)

Completed·MManhattan Eye, Ear & Throat Hospital·Phase 2·NCT00211445·11 enrolled

Breast Cancer2 trials

Treatment of Primary Breast Cancer Using PDT

Completed·UUniversity College, London·N/A·NCT02872064·12 enrolled

An Open Label, Phase II Trial of Continuous Low-Irradiance Photodynamic Therapy (CLIPT) Using Verteporfin (Visudyne®) for the Treatment of Cutaneous Metastases of Breast Cancer

Unknown status·RRogers Sciences Inc.·Phase 2·NCT02939274·15 enrolled

Pancreatic Cancer2 trials

Photoradiation With Verteporfin to Facilitate Immunologic Activity of Pembrolizumab in Unresectable, Locally Advanced or Metastatic Pancreatic Cancer

Recruiting·MMayo Clinic·Phase 2·NCT06381154·25 enrolled

Ultrasound-Guided Verteporfin Photodynamic Therapy for the Treatment of Unresectable Solid Pancreatic Tumors or Advanced Pancreatic Cancer, VERTPAC-02 Study

Completed·MMayo Clinic·Phase 2·NCT03033225·13 enrolled

AMD2 trials

Adjunctive Photodynamic Therapy + Aflibercept vs. Afilbercept Alone for PDA in NV AMD

Withdrawn·—·N/A·NCT02457026

Ranibizumab and Reduced Fluence PDT for AMD

Completed·TTexas Retina Associates·Phase 2·NCT00527475·60 enrolled

Age-Related Macular Degeneration1 trial

Reduced Fluence Photodynamic Therapy (PDT) With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration

Completed·OOklahoma State University Center for Health Sciences·Phase 4·NCT00473642·31 enrolled

17 more indications

Optical Coherence Tomography1 trial

Optical Coherence Tomography Angiography (OCTA) - Directed PDT Triple Therapy

Withdrawn·WWake Forest University Health Sciences·Phase 4·NCT04075136

Brain Tumors1 trial

Photodynamic Therapy With Porfimer Sodium in Treating Patients With Refractory Brain Tumors

Unknown status·MMedical College of Wisconsin·Phase 1·NCT00002647·24 enrolled

Safety and Efficacy1 trial

Clinical Study to Assess the Safety and Efficacy of the SpectraCure P18 System

Recruiting·SSpectraCure AB·Phase 1/2·NCT03067051·66 enrolled

Melanoma1 trial

Photodynamic Therapy in Treating Patients With Stage III or Stage IV Melanoma

Completed·QQLT Inc.·Phase 1/2·NCT00007969

Histoplasmosis1 trial

Ranibizumab Versus PDT for Presumed Ocular Histoplasmosis

Unknown status·BBarnes Retina Institute·Phase 2·NCT00546936·30 enrolled

Glioblastoma1 trial

Verteporfin for the Treatment of Recurrent High Grade EGFR-Mutated Glioblastoma

Recruiting·EEmory University·Phase 1/2·NCT04590664·24 enrolled

Neovascular AMD1 trial

Combination Bevacizumab and Verteporfin (Two Different Sequences of Treatment)in Neovascular AMD

Completed·RRetinal Consultants Medical Group·Phase 2·NCT00426998·30 enrolled

Surgical Wounds1 trial

Effect of YAP1-inhibition in Surgical Wounds.

Not yet recruiting·JJöri Pünchera·Phase 1/2·NCT06944249·24 enrolled

Prevention1 trial

SCARFREE-001: Verteporfin for Scar Prevention

Not yet recruiting·OOdense University Hospital·Phase 2·NCT07488988·12 enrolled

Treatment1 trial

Photodynamic and Pharmacologic Treatment of CNV

Completed·MMid-Atlantic Retina Consultations, Inc.·Phase 1/2·NCT00570193·41 enrolled

Prostate Cancer1 trial

Photodynamic Therapy of Primary Localized Prostate Cancer With the SpectraCure P18 System

Recruiting·SSpectraCure AB·Phase 1/2·NCT06807359·43 enrolled

ESS1 trial

A Study Testing if Medicine Can Make Pigment Epithelium Detachments Regress and Stabilize the Vision in Eyes

Terminated·NNorwegian University of Science and Technology·N/A·NCT01746875·9 enrolled

Polypoidal choroidal vasculopathy1 trial

Comparison of PDT, Intravitreal Ranibizumab and Combination for Polypoidal Choroidal Vasculopathy Under 1+PRN Regimen

Completed·SSun Yat-sen University·N/A·NCT03459144·60 enrolled

Dexamethasone1 trial

Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions (RADICAL)

Completed·QQLT Inc.·Phase 2·NCT00492284·162 enrolled

Malignancies1 trial

Photo-induction as a Means to Improve Cisplatin Delivery to Pleural Malignancies

Terminated·—·Phase 1·NCT02702700·1 enrolled

Airway obstruction1 trial

Interstitial Photodynamic Therapy Following Palliative Radiotherapy in Treating Patients With Inoperable Malignant Central Airway Obstruction

Recruiting·RRoswell Park Cancer Institute·Phase 1/2·NCT06306638·53 enrolled

Unspecified1 trial

Lucentis KAV Study

Completed·TThe Ludwig Boltzmann Institute of Retinology and Biomicroscopic Laser Surgery·Phase 3·NCT01570608·51 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 12, 2000

VISUDYNE

NDA NDA021119

Sources

References

[1]
ClinicalTrials.gov — 27 trial records for Verteporfin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Visudyne drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Verteporfin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Verteporfin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA021119). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Bausch Health Americas, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: BBausch Health Americas, Inc.

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