The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has reported that safety-related aspects of Eylea (aflibercept) may lead to “a higher-than-expected proportion of cases of increased pressure inside the eye (intraocular pressure)”, following the use of Eylea pre-filled syringes. After reviewing the evidence, the PRAC concluded that “this may be caused by incorrect handling of the pre-filled Eylea syringes”. The PRAC has reminded healthcare professionals about the use of pre-filled syringes and the appropriate measures to mitigate the highlighted risk. The approved and marketing product (aflibercept) is used for the treatment of age-related macular degeneration, macular edema and myopic choroidal neovascularization.
A number of media outlets reported that Bayer received “209 reports of increased IOP with the use of the prefilled syringe, out of 1.97 million prefilled syringes sold, a rate of 1.1 cases per 10,000”, referenced by a Ms. Doreen Schroeder, a company spokesperson. In addition, the cases were reported in a number of European Union member states and in Australia, Japan, Switzerland, and the United Kingdom. The company spokesperson identified that, “Bayer is taking these reports very seriously, and we have implemented appropriate measures so that the risk for these events is mitigated”. A summary of product characteristics is publicly available at the EMA*, specifically in regards to intraocular pressure and to relevant precautions. In particular, the public information available indicated that the most frequently observed adverse reactions for the pre-filled treatment (in at least 5% of patients treated with Eylea) showed conjunctival haemorrhage (25%), retinal haemorrhage (11%), visual acuity reduced (11%), eye pain (10%), cataract (8%), intraocular pressure increased (8%), vitreous detachment (7%) and vitreous floaters (7%).
The Electronic Medicines Compendium (EMC) (www.medicines.org.uk) compile >14,000 documents for medicines that have been checked and approved by the UK or European medicines licensing authority (the UK Medicines and Healthcare products Regulatory Agency (MHRA) or the European Medicines Agency (EMA). Advice for correct handling of the pre-filled Eylea syringes provide a useful and clear video guidance is available on the web**, (entitled: “Intravitreal injection procedure video intended for Healthcare Professionals”).