Since its introduction in 2019, brolucizumab’s safety has been called into question due to numerous reports of IOI following intravitreal injections [1]. In 2020, post-marketing data showed that there was a confirmed safety alarm of severe ocular adverse events such as retinal vasculitis, and retinal vascular occlusion that may lead to severe visual acuity loss. These events were reported at rates of 3.61 and 2.35 per 10,000 injections, respectively [1]. New concerns have been raised by Thangamathesvaran et al. on intraocular inflammation (IOI) after intravitreal faricimab (Vabysmo) [2]. Therefore, investigating underlying risk factors for IOI development following faricimab would enhance our understanding of this safety concern and inform clinical decision-making.

Many hypothesized causes, including patient susceptibility, the manufacturing process, and agent characteristics, are responsible for the IOI development after intravitreal injections [2]. The manufacturing process of faricimab may induce IOI through protein aggregates of the injection that could release silicone oil from syringes, causing IOI [3]. The Manufacturer and User Facility Device Experience (MAUDE) database of the US Food and Drug Administration (FDA) is a publicly available database representing reports of adverse events involving medical devices [4]. Herein, we aimed to share that we observed a growing number of monthly reports about similar manufacturing concerns related to faricimab which may support that handling and delivery problems could be a main risk factor of IOI.

A targeted search in MAUDE database using the terms “Faricimab” and “Vabysmo” yielded 8 reports, with the initial one recorded on October 16, 2023 (Table 1). Among these, seven reports highlighted concerns related to sterility and contamination issues associated with the needle filter. These issues included the presence of foreign substances, a faulty filter needle that fractured during vial insertion, leading to drug leakage, a complaint about a fiber wrapped around the filter needle, and a case where the stopper of the filter needle was found positioned ‘way up the middle’ of the filter needle. Furthermore, a separate incident was reported where the needle fell apart before administration. Notably, most reports were identified before any ocular manifestations. In contrast, two reports highlighted patients experiencing IOI; one was endophthalmitis and the other was not specified.

Table 1 Adverse events of faricimab reported from MAUDE database.
Full size table

In conclusion, manufacturer and handling issues may overstate the challenges and adverse events following faricimab. Prospective monitoring and surveillance system reporting are required in the future to discover potential concerns before they cause health issues or repercussions.