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Ocular anti-vascular endothelial growth factor (VEGF) therapy has brought dramatic benefits to patients with exudative age-related macular degeneration (AMD), and promises near-term advances in other major diseases such as diabetic retinopathy and macular oedema. But every silver lining has a cloud. Systemic toxicities to high-dose intravenous bevacizumab in patients with cancer1 2 have raised the question of theoretical risks such as stroke or myocardial infarction (MI) with any use of intravitreal anti-VEGF agents.3 That no increased risk of serious systemic adverse events (AE) has been shown in any of the major clinical trials of pegaptanib sodium (Macugen) or ranibizumab (Lucentis) is heartening;4–6 nevertheless, ongoing studies to monitor ocular and systemic toxicities are vital to establish the long-term safety profile of these drugs.
In this issue, Singerman and colleagues (see page 1606) present 3-year safety data from the VISION study for pegaptanib in age-related macular degeneration.7 This paper is particularly useful in confirming the low rate of ocular AEs associated with frequent intravitreal injections over 3 years. The rate of rhegmatogenous retinal detachment during year 3 was 0.03% per injection (1/3227 injections) or 0.4% per patient year (1/442 patients in year 3), and endophthalmitis ranged from 0.06% to 0.16% per injection. Once the protocol was revised to emphasise the importance of antiseptic preparation, the …
Competing interests: AEF is an advisor to Santen, Oraya and Genentech and receives research funding from Genentech, IBI Biosciences and CoMentis. RBB has served as an advisor to OSI/Eyetech Pharmaceuticals, Pfizer, Santen and Ista Pharmaceuticals; he has no financial relationship with Genentech.