The medicinal product Visudyne 15 mg, used in ophthalmology, has been unavailable in Belgium since 30 May 2020. The FAMHP is therefore making recommendations.
Since 30 May 2020 Visudyne has been unavailable. Since 1 June 2021 the marketing authorisation holder Cheplapharm has reported a temporary halt to commercialisation. The expected end date is 1 February 2022.
Experts from the FAMHP Unavailability Task Force provide the following recommendations for (hospital) pharmacists and physicians-specialists.
Use alternatives if possible.
• For exudative age-related macular degeneration
Most patients can be treated with anti-VEGF therapies.
In a subtype of this condition, polypoidal choroidopathy, anti-VEGF treatment may not adequately treat the condition, even if the treatment is increased. However, this is the only solution until Visudyne becomes available again.
• For subretinal neovascularisation
Anti-VEGF medicines are a good treatment option for this condition.
- subretinal neovascularisation with little response to anti-VEGF medicines.
Patients may temporarily receive a more severe anti-VEGF treatment to bridge the period of unavailability of Visudyne as best as possible.
- subretinal neovascularisation with a contraindication to anti-VEGF medicines (e.g. recent acute myocardial infarction or stroke).
For this subtype of condition there are no alternatives.
• For some other conditions, photodynamic therapy with Visudyne is the only treatment option. These conditions require rapid intervention, otherwise there is a risk of permanent vision loss.
There is a very limited remaining stock in the hospitals: this will be used for patients with the greatest need. The FAMHP and physicians-specialist are in contact about this.
The FAMHP is monitoring the situation and looking for additional solutions together with the European Medicines Agency (EMA).