New EU supply chain to end Visudyne shortage

4 september 2026

Critical shortage of eye medicine expected to be resolved in 2027.

A new supply chain for Visudyne (verteporfin) has been put in place in the European Union (EU), marking an important step towards resolving a long-standing shortage of the medicine. Approval of the new supply arrangements, including the registration of new manufacturing sites, has now been finalised, clearing the path to fully restore supply levels across the EU in 2027. Visudyne is an injectable medicine used to treat adults with certain serious eye conditions, including the ‘wet’ form of age-related macular degeneration and choroidal neovascularisation caused by pathologic myopia.

Resolving the shortage requires efforts to strengthen and diversify the supply chain, which until now has relied on a single US-based site for production of the active substance. The European medicines regulatory network supported the company’s work to establish the additional manufacturing sites that are expected to end the current controlled distribution system. This system was a key shortage mitigation measure taken by the Medicine Shortages Single Point of Contact (SPOC) Working Party and the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to evenly allocate limited supplies between Member States and help ensure the medicine reaches patients who need it most. Regulatory flexibilities and support were also provided by the rapporteur team and EMA staff.

This situation shows the complexity of shortages and how coordination between the European Commission, EU Member States, MSSG and SPOC Working Party can ensure fair allocation of medicines, mitigate impact and prevent future shortages.

EMA’s Head of Supply and Availability of Medicines and Devices, Monica Dias

Medicine shortages can have serious consequences for patients and public health and place a heavy burden on healthcare systems. The limited availability of Visudyne has impacted the planning, prioritisation and prescribing of patient treatment. Once the shortage is fully resolved, EMA’s shortage catalogue will be updated.

The MSSG plays a significant role in implementing key measures of the EU’s revised pharmaceutical legislation and Critical Medicines Act (CMA) — supporting a more proactive and coordinated approach to preventing and mitigating medicine shortages. This work includes carrying out vulnerability assessments of critical medicines to identify and address weaknesses in supply chains, such as overreliance on single manufacturing sites and other factors that may increase the risk of shortages.

EMA is also expanding the functionalities of the European Shortages Monitoring Platform (ESMP), a digital tool designed to enable faster, more consistent and more data-driven exchanges on potential medicines shortages between industry and regulators. The enhanced platform will strengthen the EU’s ability to monitor supply issues and take timely measures to improve availability of medicines.