Visudyne - supply shortage
Ongoing
verteporfin
Shortage
Human
Shortage information
There is a shortage of Visudyne in the EU/EEA (European Economic Area). Visudyne is used to treat adults with:
- the ‘wet’ form of age-related macular degeneration (AMD), a disease that affects the central part of the retina (called the macula) at the back of the eye;
- choroidal neovascularisation caused by pathologic myopia.
For further information on the use of the medicine, please refer to the medicine’s overview page.
There has been a shortage of Visudyne since May 2020 due to reduced manufacturing capacity. Although some supply capacity has been partially restored in the first quarter of 2022, it remains insufficient to fully meet demand. A new supply chain will be established by July 2026 and shortages are expected to continue until the end of 2026.
The shortage affects all EU/EEA Member States where the product is marketed, including Austria, Belgium, Cyprus, Czech Republic, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain and Sweden.
For up-to-date information about the status of a medicine shortage in a particular EU/EEA Member State, consult the national shortage register or contact the national competent authority.
EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) and Medicines Shortages Single Point of Contact - SPOC - Working Party are closely monitoring the supply situation and engaging with the marketing authorisation holder to mitigate the impact of the supply shortage.
• Since 2020, there is an ongoing shortage of Visudyne due to a reduction in the company’s manufacturing capacities. The shortage is now expected to last until the end of 2026 with a new supply chain being established by July 2026.
• The limited availability of Visudyne should be taken into account when planning, prioritising and prescribing treatments for age-related macular degeneration and subfoveal choroidal neovascularisation.
• Alternative treatments should be used where possible.
• Prescribers should coordinate with relevant health authorities and follow their guidance, where applicable, to ensure patients in greatest need receive therapy.
• A Medicines Shortage Communication (MSC) (to update the previous direct healthcare professional communications (DHPC)) has been sent to healthcare professionals in affected member states.
• For additional information about the supply of Visudyne, consult EMA’s shortage catalogue, your country’s shortage register (if available) or contact your national competent authority.
• Since 2020, there is an ongoing shortage of Visudyne due to a reduction in the company’s manufacturing capacities. The shortage is now expected to last until the end of 2026 with a new supply chain being established by July 2026.
• If you are being treated for age-related macular degeneration or subfoveal choroidal neovascularisation, your doctor may prescribe another medicine.
• If you have any questions, speak to your doctor or pharmacist.
• For additional information about the supply of Visudyne, consult your country’s shortage register (if available) or contact your national competent authority.
Key facts
- Medicines affected
- Visudyne
- Supply shortage status
- Ongoing
- International non-proprietary name (INN) or common name
- verteporfin
- Therapeutic area (MESH)
- Myopia, Degenerative
- Macular Degeneration
- Pharmaceutical forms affected
- Powder for solution for infusion
- Strengths affected
- 15 mg
- Availability of alternatives
- Yes
Key dates
- Start of supply shortage
- Expected resolution
- Shortages are expected to continue until the end of 2026.
- First published
- Last updated