verteporfin
Trade name: visudyne
Approved
Apr 12, 2000
Verteporfin (trade name Visudyne), a benzoporphyrin derivative, is a medication used for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis syndrome. Verteporfin can also be used to destroy tumors. Verteporfin is a 1:1 mixture of two regioisomers (I and II), VISUDYNE therapy is a two-stage process requiring administration of both verteporfin for injection and nonthermal red light. Verteporfin accumulates in these abnormal blood vessels and, when stimulated by nonthermal red light with a wavelength of 689 nm in the presence of oxygen, produces highly reactive short-lived singlet oxygen and other reactive oxygen radicals, resulting in local damage to the endothelium and blockage of the vessels. Verteporfin is also used off-label for the treatment of central serous retinopathy. Verteporfin is given intravenously, 15 minutes before laser treatment. Light activation of verteporfin results in local damage to neovascular endothelium, resulting in vessel occlusion. Damaged endothelium is known to release procoagulant and vasoactive factors through the lipo-oxygenase (leukotriene) and cyclo-oxygenase (eicosanoids such as thromboxane) pathways, resulting in platelet aggregation, fibrin clot formation and vasoconstriction. Verteporfin appears to somewhat preferentially accumulate in neovasculature, including choroidal neovasculature. However, animal models indicate that the drug is also present in the retina. Therefore, there may be collateral damage to retinal structures following photoactivation including the retinal pigmented epithelium and outer nuclear layer of the retina. The temporary occlusion of choroidal neovascularization (CNV) following VISUDYNE therapy has been confirmed in humans by fluorescein angiography. — NCATS
Clinical trial activity
60 trials · 55 clinical orgs · 2 marketing orgs
Earliest trial started May 1, 1994 (NCT00002647)
Timeline
1990s
- Jan 1, 1994
Earliest Phase 1 Sponsor(trial)
- Jan 1, 1995
QLT Photo Therapeutics — IND Organization
- Jan 1, 1995
QLT Photo Therapeutics — IND Organization
2000s
- Apr 12, 2000
QLT Photo Therapeutics — Earliest FDA Approval
- Apr 12, 2000
Bausch Health Companies — NDA Secondary Org
- Apr 12, 2000
QLT Photo Therapeutics — NDA Organization
- Apr 12, 2000
Bausch Health Companies — Marketing Organization
- Jan 1, 2002
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2002
Earliest Phase 3 Sponsor(trial)
Indications
Approved for
Studied for
- Basal Cell Carcinoma · Phase 3
- Basal Cell Nevus Syndrome · Phase 3
- Brain Neoplasms · Phase 1
- Breast Neoplasms · Phase 2
- Central Serous Chorioretinopathy · Phase 2
- Choroidal Neovascularization · Phase 4
- Dermatology · Phase 1/Phase 2
- Glioblastoma · Phase 1/Phase 2
- Livedoid Vasculopathy · Phase 4
- Macula Lutea · Phase 4
- Macular Degeneration · Phase 4
- Macular Edema · Phase 2
- Melanoma · Phase 1/Phase 2
- Myopia · Phase 3
- Myopia, Degenerative · Phase 3
- Neoplasm Metastasis · Phase 1
- Neoplasms · Phase 1/Phase 2
- Neovascularization, Pathologic · Phase 3
- Pancreatic Neoplasms · Phase 2
- Pleural Effusion, Malignant · Phase 1
- Prostatic Neoplasms · Phase 1/Phase 2
- Vision, Ocular · Phase 2
Mechanism of action
- DNAINHIBITOR
DNA inhibitor
Photodynamic therapy
Approval history
- approvedPriority reviewApr 12, 2000
Chemistry & pharmacology
SMILES
COC(=O)CCC1=C(C)c2cc3nc(cc4[nH]c(cc5nc(cc1[nH]2)c(CCC(=O)O)c5C)c(C=C)c4C)C6=CC=C(C(C(=O)OC)C36C)C(=O)OC.COC(=O)CCc7c(C)c8cc9[nH]c(cc%10nc(cc%11[nH]c(cc7n8)C(=C%11C)CCC(=O)O)C%12(C)C(C(=O)OC)C(=CC=C%10%12)C(=O)OC)c(C)c9C=C- Mol. weight
- 1437.61 g/mol
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaVerteporfin ↗
- NCATS0X9PA28K43 ↗
- ChEMBLCHEMBL5314346 ↗
- ChEMBLCHEMBL2218885 ↗
Also known as
- 18-ethenyl-4,4a-dihydro-3,4-bis(methoxycarbonyl)-4a,8,14,19-tetramethyl-23h,25h-benzo(b)porphine-9,13-dipropanoic acid monomethyl ester
- benzoporphyrin derivative monoacid ring a
- bpd-ma
- bpd-ma
- bpd verteporfin
- cl-318952
- cl-318952
- trans-18-ethenyl-4,4a-dihydro-3,4-bis(methoxycarbonyl)-4a,8,14,19-tetramethyl-23h,25h-benzo[b]porphine-9,13-dipropanoic acid monomethyl ester (1:1 mixture of two regioisomers)
- vertaporfin
- verteporfin
- verteporfin
- verteporfin
- verteporfin
- verteporfin
- verteporfin
- verteporfin
- verteporfin
- verteporfin
- verteporfin
- verteporfina
- verteporfina
- vertéporfine
- vertéporfine
- verteporfinum
- verteporfinum
- verteporphin
- verteporphin
- verteporphin
- verteporphin
- verteporphin
- verteporphin
- visudyne
- visudyne
- visudyne
- visudyne
- visudyne
- visudyne
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06944249 | Phase 1/Phase 2 (Phase 2) | May 8, 2025 | University of Geneva |
| NCT06807359 | Phase 1/Phase 2 (Phase 2) | Jan 6, 2025 | SpectraCure AB |
| NCT06381154 | Phase 2 | Oct 30, 2024 | Mayo Clinic, National Cancer Institute (NCI) |
| NCT06306638 | Phase 1/Phase 2 (Phase 2) | Oct 1, 2024 | National Cancer Institute (NCI), State University of New York, Buffalo |
| NCT04590664 | Phase 1/Phase 2 (Phase 2) | Jan 29, 2021 | Emory University, National Cancer Institute (NCI) |
| NCT04075136 | Phase 4 | Oct 1, 2019 | Wake Forest University |
| NCT03067051 | Phase 1/Phase 2 (Phase 2) | Mar 21, 2017 | SpectraCure AB |
| NCT03033225 | Phase 2 | Jan 5, 2017 | Mayo Clinic |
| NCT02821520 | Phase 4 | Jan 1, 2017 | Wenzhou Medical University |
| NCT02939274 | Phase 2 | Oct 1, 2016 | Harvard University, Rogers Sciences Inc. |
| NCT02495181 | Phase 4 | Jan 1, 2016 | Association for Innovation and Biomedical Research on Light and Image (AIBILI), European Vision Institute Clinical Research Network |
| NCT02702700 | Phase 1 | Jan 1, 2016 | University of Lausanne |
| NCT02457026 | N/A | Jan 1, 2016 | Bausch & Lomb, Duke University |
| NCT02321267 | Phase 4 | Dec 1, 2014 | Kagawa University |
| NCT02120950 | Phase 4 | May 1, 2014 | Bayer, Regeneron |
| NCT01746875 | N/A | Feb 1, 2014 | Norwegian University of Science and Technology |
| NCT01922102 | Phase 3 | Sep 11, 2013 | Novartis |
| NCT01846273 | Phase 4 | Aug 7, 2013 | Novartis |
| NCT01974622 | N/A | Apr 1, 2013 | Manhattan Eye, Ear & Throat Hospital, Northwell Health |
| NCT02872064 | N/A | Jan 1, 2013 | University of London |
Organizations
Research & Development (55)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Novartis | For profit | 14 | 8 | 3 | 2002 |
| Novelion Therapeutics | For profit | 10 | 4 | 4 | 2000 |
| Manhattan Eye, Ear & Throat Hospital | Academic/Hospital | 4 | 4 | 3 | 2002 |
| National Cancer Institute (NCI) | Government | 3 | 0 | 1 | 2021 |
| Barnes Retina Institute | Academic/Hospital | 2 | 2 | 2 | 2007 |
| Bayer | For profit | 2 | 2 | 2 | 2011 |
| Harvard University | Academic/Hospital | 2 | 1 | 2 | 2010 |
| Mayo Clinic | Academic/Hospital | 2 | 2 | 1 | 2017 |
| Regeneron | For profit | 2 | 0 | 2 | 2011 |
| SpectraCure AB | For profit | 2 | 2 | 1 | 2017 |
| Alcon | For profit | 1 | 0 | 1 | 2005 |
| Asociación para Evitar la Ceguera en México | Academic/Hospital | 1 | 1 | 1 | 2006 |
| Association for Innovation and Biomedical Research on Light and Image (AIBILI) | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Bausch & Lomb | For profit | 1 | 0 | 1 | 2016 |
| Bay Area Retina Associates | Academic/Hospital | 1 | 1 | 1 | 2006 |
| California Retina Consultants | Academic/Hospital | 1 | 1 | 1 | 2006 |
| Catholic University of Korea | Academic/Hospital | 1 | 1 | 1 | 2011 |
| Conegliano Hospital, Treviso | Academic/Hospital | 1 | 0 | 1 | 2007 |
| Duke University | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Emory University | Academic/Hospital | 1 | 1 | 1 | 2021 |
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bausch Health Companies | For profit | NDA2 | Apr 12, 2000 |
| Bausch Health Companies | For profit | MKTG | Apr 12, 2000 |
| QLT Photo Therapeutics | For profit | NDA | Apr 12, 2000 |
| QLT Photo Therapeutics | For profit | IND | Jan 1, 1995 |