The European Medicines Agency (EMA) announced on 4 September 2026 that a new, diversified supply chain for Visudyne (verteporfin) and the registration of additional manufacturing sites have been approved, clearing the path for full restoration of supply across the EU by 2027.

Why the shortage mattered

Visudyne is an injectable medicine used to treat serious eye conditions such as wet age‑related macular degeneration and choroidal neovascularisation caused by pathologic myopia. The EMA’s own briefing notes that the shortage has disrupted patient‑treatment planning and prescribing throughout the EU.

What the EMA approved

According to the EMA press release, the agency finalised approval of the new supply arrangements, which include the registration of several additional manufacturing sites. The agency said the approval “clears the path to fully restore supply levels across the EU in 2027”. The European medicines regulatory network, including the Medicine Shortages Single Point of Contact (SPOC) Working Party and the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), supported the establishment of these sites.

How the shortage arose

The packet explains that the previous shortage stemmed from reliance on a single US‑based production site for the active substance. With only one source, any disruption quickly translated into a controlled‑distribution regime for the drug throughout the EU.

Regulatory coordination behind the fix

The MSSG, which implements key measures of the EU’s revised pharmaceutical legislation and the Critical Medicines Act (CMA), played a “significant role” in coordinating the new supply chain, according to an EMA excerpt. The agency highlighted that the MSSG’s proactive approach is intended to prevent and mitigate future shortages.

Implications for the United Kingdom

Although the EMA’s announcement concerns the EU, the UK’s National Health Service (NHS) sources a substantial proportion of its Visudyne from EU manufacturers. Restoring a stable, multi‑site supply chain therefore has direct relevance for NHS ophthalmology clinics, which have faced scheduling delays and treatment interruptions because of the shortage. The EMA’s timeline – full supply by 2027 – suggests that UK patients could expect a return to normal prescribing patterns once the additional sites become operational.

Timeline of events

  • 4 September 2026 – EMA press release confirming the new supply chain and site approvals.
  • 2027 – Target date for full restoration of Visudyne supply across the EU.

What remains unknown

The EMA did not disclose the exact number of new manufacturing sites, nor the locations of the facilities. It also did not provide a detailed rollout schedule for when each site will begin production. Consequently, the precise timing of when NHS patients will see the first increase in available stock remains unclear.

What to watch next

Stakeholders will be monitoring the operational start‑up of the newly approved sites and any subsequent updates from the MSSG on distribution logistics. If the supply chain diversifies as intended, the controlled‑distribution regime that has limited Visudyne availability should be lifted well before the 2027 target, offering earlier relief for UK eye‑care services.