Summary
The European Medicines Agency says new manufacturing sites for Visudyne have been approved, reducing reliance on a single US-based active-substance site. Full supply across the European Union is expected to be restored in 2027.
The European Medicines Agency (EMA) says a new supply chain for Visudyne, an injectable medicine containing verteporfin, has been established in the European Union. Approval of the new supply arrangements, including registration of additional manufacturing sites, has been finalised.
The changes are intended to end a long-running shortage and restore supply levels across the EU in 2027. Visudyne is used in adults with certain serious eye conditions, including the wet form of age-related macular degeneration and choroidal neovascularisation caused by pathologic myopia.
Why the supply chain is changing
Until now, production of Visudyne’s active substance had relied on a single site in the United States. The additional manufacturing sites are intended to diversify that supply chain and reduce its dependence on one production location.
The European medicines regulatory network supported the company in establishing the new sites. The EMA says regulatory flexibilities and assistance were provided by the rapporteur team and EMA staff, helping complete the changes needed for the new supply arrangements.
Limited availability has affected the planning, prioritisation and prescribing of treatment. While supplies remain constrained, a controlled distribution system has been used to allocate available medicine between EU Member States. That system was introduced by the Medicine Shortages Single Point of Contact Working Party and the Executive Steering Group on Shortages and Safety of Medicinal Products to distribute limited stocks more evenly and help ensure that patients who need Visudyne can receive it.
What the 2027 target means
The EMA describes the new arrangements as clearing the path to fully restore supply levels across the EU in 2027. This is a planned resolution rather than an immediate return to unrestricted availability: the controlled distribution measures are part of the current response while the new supply chain is put into operation.
Once the shortage has been fully resolved, the EMA says its shortage catalogue will be updated. The notice does not provide a specific month in 2027 for full restoration or an interim supply schedule.
A broader approach to medicine shortages
The Visudyne case illustrates why medicine shortages can arise even when a product remains authorised and clinically needed. A supply chain concentrated at one manufacturing site can be vulnerable to disruption, making diversification an important part of shortage prevention.
The EMA says the European Commission, EU Member States, the Executive Steering Group on Shortages and Safety of Medicinal Products, and the Medicine Shortages Single Point of Contact Working Party coordinated measures to mitigate the shortage and allocate available stocks fairly.
This work forms part of the EU’s wider response under its revised pharmaceutical legislation and Critical Medicines Act. The medicines-shortage groups are carrying out vulnerability assessments of critical medicines to identify weaknesses such as overreliance on single manufacturing sites.
The EMA is also expanding the European Shortages Monitoring Platform, a digital system for exchanging information between industry and regulators about potential supply problems. The agency says the enhanced platform is intended to support faster, more consistent and more data-driven action when shortages threaten medicine availability.