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Context:
In France, unlike in the US, patients often purchase their own anti–VEGF (vascular endothelial growth factor) injections from a pharmacy and transport them to their ophthalmologist. This raises concerns about temperature control during storage and transport. -
Study Results (Ben Ghezala et al.):
- All 38 patient-purchased anti-VEGF agents exceeded the recommended storage temperature limit of 8 °C.
- Most were above this threshold for more than 12 hours.
- 28.9% (11 samples) were above 8 °C for 48 hours or more.
- Prolonged temperature excursions can cause bacterial growth, protein degradation, aggregation, and reduced drug efficacy.
- No ocular adverse events were reported in this study.
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Manufacturer Guidelines:
Ranibizumab, aflibercept, and faricimab-svoa can be stored at 20–25 °C for up to 24 hours before administration.
🔍 Expert Commentary & Concerns
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Protein Aggregation Risks:
- Aggregates can be immunogenic and may contribute to post-injection intraocular inflammation (IOI).
- Ranibizumab appears less prone to aggregation than bevacizumab or aflibercept in certain conditions.
- Silicone oil droplets in syringes can interact with proteins, increasing immunogenicity.
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Potential Links to Inflammation:
- Faricimab-svoa, like bevacizumab and aflibercept, contains a fragment crystallizable (Fc) domain, which may have “hot spots” for aggregation.
- Ranibizumab lacks this Fc domain.
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Regulatory Questions:
- Current temperature guidelines may be adequate for most agents, but systematic studies are lacking.
- Seasonal temperature variations (e.g., summer heat) could increase risks of aggregation, bacterial contamination, and endophthalmitis.
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Clinical Implications:
- No definitive method exists to distinguish infectious endophthalmitis from noninfectious inflammation after injection.
- Certain clinical signs (pain, eyelid edema, hypopyon, etc.) favor an infectious diagnosis.
- Careful judgment and close follow-up are essential.
Citation: Ben Ghezala I, Steinberg LA, Sibert M, Lazzarotti A, Ambresin M, Gabrielle PH, Creuzot-Garcher C. Temperature excursion of intravitreal anti-VEGF agents during home storage. JAMA Ophthalmology. Published online January 16, 2025. doi:[10.1001/jamaophthalmol.2024.5884]
