Due to a delay in production, the availability of Visudyne, a medicine used in ophthalmology, has been limited since 9 December 2024. This situation is expected to continue until at least the end of April 2026. The experts of the FAMHP’s Unavailability Task Force are making the following recommendations to (hospital) pharmacists and medical specialists.
1. Use alternatives where possible
• For exudative age-related macular degeneration
Most of these patients can be treated with anti-VEGF therapies.
• For subretinal neovascularisation
Anti-VEGF medicines are a good therapeutic tool.
The exception is subretinal neovascularisation with poor response to anti-VEGF medicines. In these patients, anti-VEGF therapy can be temporarily intensified to help them through the period of limited availability of Visudyne.
2. Prioritisation
For a number of conditions, Visudyne photodynamic therapy is the only treatment option.
• Patients with the highest priority for Visudyne photodynamic therapy
- Patients with monocular vision or visual acuity of the other eye ≤ 0.5 with:
- choroidal hemangioma with submacular fluid;
- central serous chorioretinopathy with persistent subfoveal fluid (no improvement after three months) documented by OCT, with a source of leakage inaccessible to focal laser;
- polypoidal choroidal vasculopathy with foveal intra- and/or subretinal fluid and/or (para)foveal hard exudates, not accessible to focal laser, worsening despite anti-VEGF treatment every four weeks, even after changing the molecule;
- non-inflammatory choroidal neovascularisation with foveal intraretinal fluid or subfoveal fluid > 200 µm and/or (para)foveal hard exudates, worsening despite anti-VEGF treatment every four weeks, even after changing the molecule.
- Children < 18 years with submacular fluid due to a choroidal hemangioma.
- Subretinal neovascularisation with contraindication for anti-VEGF medicines (e.g. myocardial infarction or recent CVA (less than three months)).
• Patients with a high priority for Visudyne photodynamic therapy
- Choroidal hemangioma with extensive extramacular fluid in patients with monocular vision or visual acuity in the other eye < 0.5.
- Choroidal hemangioma with submacular fluid and visual acuity in the other eye > 0.5.
- Central serous chorioretinopathy with persistent subfoveal fluid (no improvement after three months or gradual improvement, but persisting after six months) documented by OCT, with a source of leakage inaccessible to focal laser, and visual acuity of the other eye > 0.5.
- Polypoidal choroidal vasculopathy with foveal intra- and/or subretinal fluid and/or (para)foveal hard exudates, not accessible to focal laser, worsening despite anti-VEGF treatment every four weeks, even after changing the molecule, and visual acuity of the other eye > 0.5.
If using a half-dose of the medicine (depending on the indication), the members of the Task Force recommend that one bottle be shared between two successively scheduled patients, in compliance with aseptic conditions for the preparation of solutions for infusion.
To ensure rational and transparent use of the limited stock of Visudyne, the medicine can only be dispensed after prior approval from the Belgian Retina Society (BRS). The application procedure must be initiated using the form provided. No medicine will be supplied without this approval.
Monitoring by the FAMHP
The Federal Agency for Medicines and Health Products (FAMHP) is closely monitoring the situation and any planned deliveries, and remains in regular contact with the company, its distribution partner and the European Medicines Agency (EMA).