An ongoing global shortage of verteporfin (Visudyne®) limits the treatment with photodynamic therapy used for several chorioretinal diseases, leading to possible irreversible vision loss. |
The worldwide supply of verteporfin appears to be manufactured by a single factory situated in the United States and is distributed by different companies per region. |
Over the past years, deliveries of batches of verteporfin have been scarce, unpredictable, and poorly communicated on by the responsible companies. |
National and international steps can be undertaken to monitor medicine shortages, and to fairly distribute remaining medication within the country or within a region. |
Introduction
Photodynamic Therapy in Ophthalmology
Manufacturing
Shortage
Official Communication on the Shortage
Unofficial Communication on the Shortage and Deliveries of Verteporfin Batches in The Netherlands
Equal Distribution of Verteporfin Batches Between Countries
Current Measures
The Netherlands
Category A: Patients with the highest priority of undergoing PDT |
1. Patients with one functional eye or a maximum BCVA of the other eye of 0.5 Snellen decimal with |
(a) Choroidal hemangioma with submacular fluid |
(b) CSC with OCT-documented persisting fluid during 3 months with a leakage point that is not accessible for focal laser treatment |
2. Children (< 18 years old) with a choroidal hemangioma with submacular fluid |
3. Patients with one functional eye or a maximum BCVA of the other eye of 0.3 Snellen decimal with |
(a) Polypoidal choroidal vasculopathy with foveal intraretinal or subretinal fluid, or (para)foveal hard exudates deteriorating despite 4-weekly intravitreal injections with anti-VEGF agents, after having tried at least two different agents. The polypoidal lesion should not be accessible for focal laser treatment, and should be eligible for treatment with half-dose PDT |
(b) Non-inflammatory choroidal neovascularization with foveal intraretinal or subretinal fluid, or (para)foveal hard exudates deteriorating despite 4-weekly intravitreal injections with anti-VEGF agents. The patient must have shown insufficient improvement after bevacizumab, ranibizumab, and aflibercept, and one of the following: brolucizumab or faricimab |
Category B: Patients with a high priority of undergoing PDT |
1. Patients with choroidal hemangioma with extensive subretinal fluid, either macular or extramacular |
2. Patients with choroidal hemangioma with submacular fluid and a BCVA of the other eye of > 0.5 Snellen decimal |
3. Patients with CSC with OCT-documented persisting subfoveal fluid with a leakage point that is not accessible for focal laser treatment and a BCVA of the other eye of > 0.5 Snellen decimal For a first episode of CSC, the subfoveal fluid should exist for at least 3–4 months For a recurrence of CSC within 2 years, the subfoveal fluid should exist for at least 2–3 months |
4. Patients with polypoidal choroidal vasculopathy with foveal intraretinal or subretinal fluid, or (para)foveal hard exudates deteriorating despite 4-weekly intravitreal injections with anti-VEGF agents, after having tried at least two different agents. The polypoidal lesion should not be accessible for focal laser treatment, and the BCVA of the other eye may be > 0.5 Snellen decimal |